The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Zoom 71 Reperfusion Catheter; Zoom Aspiration Tubing.
| Device ID | K211476 |
| 510k Number | K211476 |
| Device Name: | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Contact | Teri Nguyen |
| Correspondent | Teri Nguyen Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-12 |
| Decision Date | 2021-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030450 | K211476 | 000 |