The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Interpleural Anesthesia Catheter.
| Device ID | K971851 |
| 510k Number | K971851 |
| Device Name: | INTERPLEURAL ANESTHESIA CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Contact | Ridwan Hardy |
| Correspondent | Ridwan Hardy AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1998-01-22 |
| Summary: | summary |