# Contego Medical, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 8 (2018–2025): 7 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Contego Medical, Inc. (6); Contego Medical, LLC (2)
- Product codes: QEW (4), LIT (3), NIM (1)
- 510(k) review time since 2016: median 58 days, against 118 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Inari Medical, Inc.: 1 (https://510kreport.com/company/inari-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- Angioslide, Ltd.: 1 (https://510kreport.com/company/angioslide)
- Ev3, Inc.: 1 (https://510kreport.com/company/ev3)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)

## Its most-cited devices
- K223897: Excipio LV Thrombectomy Device (2023), cited by 1
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (2018), cited by 1
- K221204: Excipio SV Thrombectomy Device (2022), cited by 1

## Recent decisions
- K251485: Excipio LV Prime Thrombectomy Device (Jun 13, 2025)
- P240009: Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (Oct 11, 2024)
- K230030: Excipio SV Aspiration Catheter and Tubing (May 30, 2023)
- K223897: Excipio LV Thrombectomy Device (Feb 17, 2023)
- K221204: Excipio SV Thrombectomy Device (Jun 23, 2022)
- K221339: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (Jun 9, 2022)
- K181529: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (Dec 6, 2018)
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (Sep 6, 2018)

Source page: https://510kreport.com/company/contego-medical