Penumbra System JET73DVELSYS-A
Penumbra System JET73DVELSYS-A is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K173761 on 17 Aug 2018 (3 earlier submissions) and listed in FDA GUDID since 28 Sep 2018 (UDI-DI 00815948020146), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815948020146 | Date28 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173761 | Date17 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00815948020146
- FDA 510(k) database K173761
- FDA 510(k) database K162901
- FDA 510(k) database K152840
- FDA 510(k) database K151623
Across registries
- FDA 510(k) K173761 decided 17 Aug 2018 Active
- FDA GUDID UDI-DI 00815948020146 listed 28 Sep 2018 Listed
Recalls
-
- Terminated Z-2702-2017
Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
Timeline
- Cleared FDA 510(k) K151623
- Cleared FDA 510(k) K152840
- Cleared FDA 510(k) K162901
- Recall initiated FDA recalls Z-2702-2017
- Cleared FDA 510(k) K173761
- Listed FDA GUDID 00815948020146
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Penumbra System
- Generic name
- Vascular microcatheter
- Model / Ref / Catalog
- JET73DVELSYS-A, JET73DVELSYS
- Primary DI / UDI-DI
- 00815948020146
- FDA product code
- DQY, NRY
- GMDN term
- Vascular microcatheter
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
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