The following data is part of a premarket notification filed by Acrostak (schweiz) Ag with the FDA for M-cath Microcatheter.
| Device ID | K171176 |
| 510k Number | K171176 |
| Device Name: | M-CATH Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Acrostak (Schweiz) AG Stegackerstrasse 14 Winterthur, CH 8409 |
| Contact | Carmen Herraez |
| Correspondent | Carmen Herraez Acrostak (Schweiz) AG Stegackerstrasse 14 Winterthur, CH 8409 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2017-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640132622157 | K171176 | 000 |
| 07640132622706 | K171176 | 000 |
| 07640132622690 | K171176 | 000 |