The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Embolectomy Aspiration System [indigo System].
| Device ID | K142870 |
| 510k Number | K142870 |
| Device Name: | Penumbra Embolectomy Aspiration System [INDIGO System] |
| Classification | Catheter, Embolectomy |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Michael Mahl |
| Correspondent | Michael Mahl PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-01 |
| Decision Date | 2015-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017624 | K142870 | 000 |
| 00815948022300 | K142870 | 000 |
| 00815948022270 | K142870 | 000 |
| 00815948022249 | K142870 | 000 |
| 00815948022973 | K142870 | 000 |
| 00815948022966 | K142870 | 000 |
| 00815948022959 | K142870 | 000 |
| 00815948022331 | K142870 | 000 |
| 00815948022317 | K142870 | 000 |
| 00815948022287 | K142870 | 000 |
| 00815948022256 | K142870 | 000 |
| 00815948024342 | K142870 | 000 |
| 00815948024335 | K142870 | 000 |
| 00815948024281 | K142870 | 000 |
| 00815948023857 | K142870 | 000 |
| 00815948020405 | K142870 | 000 |
| 00815948020412 | K142870 | 000 |
| 00814548017440 | K142870 | 000 |
| 00814548016290 | K142870 | 000 |
| 00814548016283 | K142870 | 000 |
| 00814548016276 | K142870 | 000 |
| 00814548016269 | K142870 | 000 |
| 00814548016252 | K142870 | 000 |
| 00814548016245 | K142870 | 000 |
| 00814548016221 | K142870 | 000 |
| 00814548016214 | K142870 | 000 |
| 00814548016153 | K142870 | 000 |
| 00814548016146 | K142870 | 000 |
| 00815948020481 | K142870 | 000 |
| 00815948020450 | K142870 | 000 |
| 00815948020436 | K142870 | 000 |
| 00815948023802 | K142870 | 000 |