The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for 0.071” Id Mantaray Reperfusion Catheter, 0.055” Id Mantaray Reperfusion Catheter, 0.045” Id Mantaray Reperfusion Catheter, 0.035” Id Mantaray Reperfusion Catheter.
| Device ID | K183043 |
| 510k Number | K183043 |
| Device Name: | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Contact | Jake Wolenberg |
| Correspondent | Jake Wolenberg Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030085 | K183043 | 000 |
| 00812212030078 | K183043 | 000 |
| 00812212030092 | K183043 | 000 |
| 00812212030061 | K183043 | 000 |
| 00812212030191 | K183043 | 000 |
| 00812212030184 | K183043 | 000 |