The following data is part of a premarket notification filed by Cimpax Aps with the FDA for C-cat Anaesthesia Catheter Kit.
| Device ID | K191470 |
| 510k Number | K191470 |
| Device Name: | C-CAT Anaesthesia Catheter Kit |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | Cimpax ApS Lille Pilevang 4 Slangerup, DK 3550 |
| Contact | Patrick Busch-madsen |
| Correspondent | Kathleen Johnson Medical Device Approvals, Inc. 104 Harrison Ave. Fairfield, IA 52556 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2019-10-25 |
| Summary: | summary |