The following data is part of a premarket notification filed by Imds Operations B.v. with the FDA for Recross.
| Device ID | K210431 |
| 510k Number | K210431 |
| Device Name: | ReCross |
| Classification | Catheter, Percutaneous |
| Applicant | IMDS Operations B.V. Ceintuurbaan Noord 150 Roden, NL 9301 Nz |
| Contact | Edwin Schulting |
| Correspondent | Edwin Schulting IMDS Operations B.V. Ceintuurbaan Noord 150 Roden, NL 9301 Nz |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-12 |
| Decision Date | 2021-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718481740309 | K210431 | 000 |