Chrysalis Intelligence · Sponsors · Contego Medical, Inc.

Contego Medical, Inc.

Raleigh, NC, US · 5 510(k) clearances · 9 PMAs · 2 recalls

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Total clearances
5
2022-06-09 → 2025-06-13
Last 12 months
0
Product codes
2
Most recent
2025-06-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 4 2025-06-13
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 1 2022-06-09
Class III

PMA approvals (9)

Total PMA records
9
Originals + supplements
Distinct product codes
1
First decision
2024-10-11
Most recent
2026-07-29
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-29 P240009-S012 Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection 30-Day Notice NIM Stent, Carotid Unknown
2026-05-27 P240009-S011 Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection 30-Day Notice NIM Stent, Carotid Unknown
2026-05-08 P240009-S008 Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection 30-Day Notice NIM Stent, Carotid Unknown
2026-01-28 P240009-S007 Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection 135 Review Track For 30-Day Notice NIM Stent, Carotid Unknown
2025-09-19 P240009-S005 Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection – (Neuroguard I 30-Day Notice NIM Stent, Carotid Unknown
2025-08-22 P240009-S004 Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection Special (Immediate Track) NIM Stent, Carotid Unknown
2024-11-15 P240009-S002 Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection 30-Day Notice NIM Stent, Carotid Unknown
2024-11-15 P240009-S001 Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection 30-Day Notice NIM Stent, Carotid Unknown
2024-10-11 P240009 Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection Original NIM Stent, Carotid Unknown
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2026-06-29
DateSeverityStatusRecall # ProductCodeReason
2026-06-29 Class II Ongoing Z-2911-2026 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP … — Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may …
2025-09-04 Class II Ongoing Z-0131-2026 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP … — Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during…
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-06-13 K251485 Excipio LV Prime Thrombectomy Device QEW Class II Cardiovascular
2023-05-30 K230030 Excipio SV Aspiration Catheter and Tubing QEW Class II Cardiovascular
2023-02-17 K223897 Excipio LV Thrombectomy Device QEW Class II Cardiovascular
2022-06-23 K221204 Excipio SV Thrombectomy Device QEW Class II Cardiovascular
2022-06-09 K221339 Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection LIT Class II Cardiovascular
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence