Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K161640
Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · decided 2016-07-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ACE | 5MAXACE068KIT-R | PENUMBRA, INC. | NRY | 00815948022850 |
| Penumbra System | 5MAXACE068L120-B | PENUMBRA, INC. | NRY | 00814548017501 |
| Penumbra System | 5MAXACE068-A | PENUMBRA, INC. | NRY | 00814548016580 |
| Penumbra System | 5MAXACE068L115-B | PENUMBRA, INC. | NRY | 00814548017488 |
| Penumbra System | 5MAXACE068L125-A | PENUMBRA, INC. | NRY | 00814548016566 |
| Penumbra System | 5MAXACE068KIT-B | PENUMBRA, INC. | NRY | 00814548017532 |
| Penumbra System | 5MAXACE068L127-A | PENUMBRA, INC. | NRY | 00814548016573 |
| Penumbra System | 5MAXACE068L127-B | PENUMBRA, INC. | NRY | 00814548017518 |
| Penumbra System | 5MAXACE068L125-B | PENUMBRA, INC. | NRY | 00814548017495 |
| ACE | 5MAXACE068KIT | PENUMBRA, INC. | NRY | 00814548016603 |
| Penumbra System | 5MAXACE068-B | PENUMBRA, INC. | NRY | 00814548017525 |
| Penumbra System | 5MAXACE068L115-A | PENUMBRA, INC. | NRY | 00814548016542 |
| ACE | 5MAXACE068L127 | PENUMBRA, INC. | NRY | 00814548016528 |
| ACE | 5MAXACE068L125 | PENUMBRA, INC. | NRY | 00814548016511 |
| ACE | 5MAXACE068L115 | PENUMBRA, INC. | NRY | 00814548016498 |
| ACE | 5MAXACE068L120 | PENUMBRA, INC. | NRY | 00814548016504 |
| ACE | 5MAXACE068 | PENUMBRA, INC. | NRY | 00814548016535 |
| Penumbra System | 5MAXACE068L120-A | PENUMBRA, INC. | NRY | 00814548016559 |
| Penumbra System | 5MAXACE068KIT-A | PENUMBRA, INC. | NRY | 00814548016597 |
| ACE | 5MAXACE068-R | PENUMBRA, INC. | NRY | 00815948022843 |