The following data is part of a premarket notification filed by Imds Operations B.v. with the FDA for Nhancer Rx.
| Device ID | K200324 |
| 510k Number | K200324 |
| Device Name: | NHancer Rx |
| Classification | Catheter, Percutaneous |
| Applicant | IMDS Operations B.V. Ceintuurbaan Noord 150 Roden, NL 9301 Na |
| Contact | E Schulting |
| Correspondent | E. Schulting IMDS Operations B.V. Ceintuurbaan Noord 150 Roden, NL 9301 Na |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-10 |
| Decision Date | 2020-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718481740231 | K200324 | 000 |