The following data is part of a premarket notification filed by Bmw Medical, Inc. with the FDA for Clampless Valved Catheter - Tunneled (cvc-t).
| Device ID | K963806 |
| 510k Number | K963806 |
| Device Name: | CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | BMW MEDICAL, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 -4959 |
| Contact | Phi Triolo |
| Correspondent | Phi Triolo BMW MEDICAL, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 -4959 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1996-12-12 |
| Summary: | summary |