Chrysalis Intelligence · Sponsors · Route 92 Medical, Inc.

Route 92 Medical, Inc.

San Mateo, CA, US · 11 510(k) clearances · 5 recalls (5 Class I)

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Total clearances
11
2020-01-13 → 2025-05-19
Last 12 months
0
Product codes
3
Most recent
2025-05-19
Name variants in FDA filings: Route 92 Medical, Inc. / Route 92 Medical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QJP — — — 7 2024-10-02
NRY Catheter, Thrombus Retriever Class II Cardiovascular 3 2025-05-19
DQY — — — 1 2020-01-13
Safety

Recalls (5)

Class I (serious)
5
Risk of injury / death
Total recalls
5
Currently ongoing
5
Most recent
2024-03-08
DateSeverityStatusRecall # ProductCodeReason
2024-03-08 Class I Ongoing Z-1614-2024 Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i… — Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
2024-03-08 Class I Ongoing Z-1613-2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de… — Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
2024-03-08 Class I Ongoing Z-1612-2024 Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int… — Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
2024-03-08 Class I Ongoing Z-1611-2024 Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio… — Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
2024-03-08 Class I Ongoing Z-1610-2024 Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev… — Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2025-05-19 K243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set NRY Class II Cardiovascular
2024-10-02 K240529 8F Modified Sheath System QJP — —
2024-04-23 K233329 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set NRY Class II Cardiovascular
2023-08-15 K231583 Route 92 Medical Full Length 054 Access System QJP — —
2023-04-11 K223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set NRY Class II Cardiovascular
2022-10-04 K222743 Route 92 Medical Full Length 070 Access System QJP — —
2021-07-27 K210635 Route 92 Medical Full Length 088 Access System QJP — —
2020-11-11 K203043 Route 92 Medical 070 Access System QJP — —
2020-08-14 K201518 Route 92 Medical 088 Access System QJP — —
2020-04-18 K200121 Route 92 Medical 088 Access System, 110 cm QJP — —
2020-01-13 K191717 Route 92 Medical Sheath System DQY — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence