510(k) K202251 ยท NRY Catheter, Thrombus Retriever
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Aug 31, 2020 |
| Received | Aug 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers as Terminated |
NRY | None listed |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the P Terminated |
NRY | None listed |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of t Terminated |
NRY | None listed |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.