The following data is part of a premarket notification filed by Tfx Medical Group with the FDA for Tfx Medical Stylet Catheter.
| Device ID | K992664 |
| 510k Number | K992664 |
| Device Name: | TFX MEDICAL STYLET CATHETER |
| Classification | Stylet, Catheter |
| Applicant | TFX MEDICAL GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont TFX MEDICAL GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 2000-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704519729 | K992664 | 000 |