The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Trocar Thoracic Catheter.
| Device ID | K863247 |
| 510k Number | K863247 |
| Device Name: | AXIOM TROCAR THORACIC CATHETER |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Contact | Roger Wood |
| Correspondent | Roger Wood 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 | 1986-08-22 |
| Decision Date | 1986-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6655222363 | K863247 | 000 |
| M6655222323 | K863247 | 000 |
| M6655222283 | K863247 | 000 |
| M6655222243 | K863247 | 000 |
| M6655222203 | K863247 | 000 |
| M6655222163 | K863247 | 000 |
| M6655222123 | K863247 | 000 |
| M6655222103 | K863247 | 000 |
| M6655222083 | K863247 | 000 |