The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Pinpoint Gt Needle Guide Kits.
| Device ID | K171348 |
| 510k Number | K171348 |
| Device Name: | Pinpoint GT Needle Guide Kits |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | C.R. Bard, Inc. 650 North 5600 West Salt Lake City, UT 84116 |
| Contact | Christopher M. Phillips |
| Correspondent | Christopher M. Phillips C.R. Bard, Inc. 650 North 5600 West Salt Lake City, UT 84116 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-05-22 |
| Summary: | summary |