The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Zoom (71, 55, 45, 35) Reperfusion Catheters; Zoom Aspiration Tubing.
| Device ID | K210996 |
| 510k Number | K210996 |
| Device Name: | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Contact | Kristin Ellis |
| Correspondent | Kristin Ellis 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 | 2021-04-02 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030443 | K210996 | 000 |