The following data is part of a premarket notification filed by Fetzer Medical Gmbh & Co. Kg with the FDA for Vessel Dilator.
| Device ID | K163524 |
| 510k Number | K163524 |
| Device Name: | Vessel Dilator |
| Classification | Dilator, Vessel, Surgical |
| Applicant | Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE 78532 |
| Contact | Harald Jung |
| Correspondent | Harald Jung Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE 78532 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G277G2C520590 | K163524 | 000 |
| 00840343704322 | K163524 | 000 |
| 00840343704315 | K163524 | 000 |
| 00840343704308 | K163524 | 000 |
| 00840343704292 | K163524 | 000 |
| 00840343704285 | K163524 | 000 |
| 00840343716370 | K163524 | 000 |
| 00840343716363 | K163524 | 000 |
| 00840343716325 | K163524 | 000 |
| 00840343716318 | K163524 | 000 |
| 00840343704339 | K163524 | 000 |
| 00840343704346 | K163524 | 000 |
| 00840343704353 | K163524 | 000 |
| G277G2C520580 | K163524 | 000 |
| G277G2C520570 | K163524 | 000 |
| G277G2C520560 | K163524 | 000 |
| G277G2C520550 | K163524 | 000 |
| G277G2C520540 | K163524 | 000 |
| G277G2C520530 | K163524 | 000 |
| G277G2C520520 | K163524 | 000 |
| G277G2C520510 | K163524 | 000 |
| 00840343704360 | K163524 | 000 |
| 00840343716295 | K163524 | 000 |