The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Pinpoint Gt Safety Introducer Needle.
| Device ID | K142445 |
| 510k Number | K142445 |
| Device Name: | PINPOINT GT SAFETY INTRODUCER NEEDLE |
| Classification | Introducer, Catheter |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Amy Mcmanus |
| Correspondent | Amy Mcmanus C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-04-13 |
| Summary: | summary |