The following data is part of a premarket notification filed by Tfx Medical, Inc. with the FDA for Tfx Medical Introducer Assembly.
| Device ID | K993191 |
| 510k Number | K993191 |
| Device Name: | TFX MEDICAL INTRODUCER ASSEMBLY |
| Classification | Introducer, Catheter |
| Applicant | TFX MEDICAL, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Julia A Beaumont |
| Correspondent | Julia A Beaumont TFX MEDICAL, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 2000-03-24 |
| Summary: | summary |