The following data is part of a premarket notification filed by Wallaby Medical with the FDA for Esperance Aspiration Catheter System.
| Device ID | K211697 |
| 510k Number | K211697 |
| Device Name: | Esperance Aspiration Catheter System |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Wallaby Medical 22901 Mill Creek Drive Laguna Hills, CA 92653 |
| Contact | Nathaniel Knock |
| Correspondent | Nathaniel Knock Wallaby Medical 22901 Mill Creek Drive Laguna Hills, CA 92653 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2021-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970908211874 | K211697 | 000 |
| 06970908211867 | K211697 | 000 |
| 06970908211850 | K211697 | 000 |
| 06970908211133 | K211697 | 000 |
| 06970908211126 | K211697 | 000 |
| 06970908211119 | K211697 | 000 |