The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ts Percutaneous Arterial/venus Catheter Intro Set.
| Device ID | K955785 |
| 510k Number | K955785 |
| Device Name: | TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET |
| Classification | Introducer, Catheter |
| Applicant | C.R. BARD, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | Robert T Miragiluolo |
| Correspondent | Robert T Miragiluolo C.R. BARD, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-21 |
| Decision Date | 1996-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169014637 | K955785 | 000 |
| 20643169014378 | K955785 | 000 |
| 20643169014361 | K955785 | 000 |
| 20643169014354 | K955785 | 000 |
| 20643169014347 | K955785 | 000 |
| 20643169014309 | K955785 | 000 |
| 20643169014095 | K955785 | 000 |
| 20643169014088 | K955785 | 000 |
| 20643169014071 | K955785 | 000 |
| 20643169014057 | K955785 | 000 |
| 20643169014033 | K955785 | 000 |
| 20643169014385 | K955785 | 000 |
| 20643169014392 | K955785 | 000 |
| 20643169014408 | K955785 | 000 |
| 20643169014606 | K955785 | 000 |
| 20643169014590 | K955785 | 000 |
| 20643169014569 | K955785 | 000 |
| 20643169014538 | K955785 | 000 |
| 20643169014521 | K955785 | 000 |
| 20643169014491 | K955785 | 000 |
| 20643169014460 | K955785 | 000 |
| 20643169014453 | K955785 | 000 |
| 20643169014446 | K955785 | 000 |
| 20643169014415 | K955785 | 000 |
| 20643169013999 | K955785 | 000 |