The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Atraum Trocar Catheter.
| Device ID | K852241 |
| 510k Number | K852241 |
| Device Name: | AXIOM ATRAUM TROCAR CATHETER |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Contact | John A Kemp |
| Correspondent | John A Kemp AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-23 |
| Decision Date | 1985-06-14 |