Chrysalis Intelligence · Sponsors · Cordis Corporation

Cordis Corporation

Miami Lakes, FL, US · 6 510(k) clearances · 15 recalls (6 Class I)

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Total clearances
6
2020-09-11 → 2022-04-06
Last 12 months
0
Product codes
4
Most recent
2022-04-06
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 3 2021-04-23
NTE Temporary Carotid Catheter For Embolic Capture Class II Cardiovascular 1 2022-04-06
DQO Catheter, Intravascular, Diagnostic Class II Cardiovascular 1 2022-02-17
DYB Introducer, Catheter Class II Cardiovascular 1 2021-02-26
Safety

Recalls (15)

Class I (serious)
6
Risk of injury / death
Total recalls
15
Currently ongoing
6
Most recent
2021-10-01
DateSeverityStatusRecall # ProductCodeReason
2021-10-01 Class II Ongoing Z-0221-2022 SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malign… — There is a potential for distal tip dislodgement or separation.
2021-10-01 Class II Ongoing Z-0220-2022 SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna… — There is a potential for distal tip dislodgement or separation.
2021-10-01 Class II Ongoing Z-0219-2022 SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant… — There is a potential for distal tip dislodgement or separation.
2021-10-01 Class II Ongoing Z-0218-2022 SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna… — There is a potential for distal tip dislodgement or separation.
2021-10-01 Class II Ongoing Z-0217-2022 SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna… — There is a potential for distal tip dislodgement or separation.
2021-10-01 Class II Ongoing Z-0216-2022 SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant… — There is a potential for distal tip dislodgement or separation.
2021-07-21 Class I Terminated Z-2432-2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C — Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter be…
2021-07-21 Class I Terminated Z-2431-2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B — Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter be…
2021-07-21 Class I Terminated Z-2430-2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A — Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter be…
2021-07-21 Class I Terminated Z-2429-2021 Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB — Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter be…
2021-07-21 Class I Terminated Z-2428-2021 Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB — Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter be…
2021-07-19 Class II Terminated Z-2235-2021 Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X — The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer ove…
2021-06-09 Class II Terminated Z-2079-2021 Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring pe… — The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
2021-02-11 Class I Completed Z-1257-2021 PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC06… — Distal tip may become separated from the lumen wire in specific lots.
2020-01-08 Class II Terminated Z-1477-2020 Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S — Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2022-04-06 K220654 ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire NTE Class II Cardiovascular
2022-02-17 K212977 SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands DQO Class II Cardiovascular
2021-04-23 K210626 SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter LIT Class II Cardiovascular
2021-02-26 K202167 Brite Tip Radianz Guiding Sheath DYB Class II Cardiovascular
2020-10-09 K201377 SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter LIT Class II Cardiovascular
2020-09-11 K201333 SABER .035 PTA Dilatation Catheter LIT Class II Cardiovascular
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence