The following data is part of a premarket notification filed by Rapid Medical Ltd. with the FDA for Tigertriever 13 Revascularization Device.
| Device ID | K220808 |
| 510k Number | K220808 |
| Device Name: | Tigertriever 13 Revascularization Device |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Rapid Medical Ltd. Carmel Building, POB 337 Yokneam, IL 2069205 |
| Contact | Orit Yaniv |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290015107300 | K220808 | 000 |