The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerloc Max Power-injectable Infusion Set And Safestep Huber Needle Set.
| Device ID | K171735 |
| 510k Number | K171735 |
| Device Name: | PowerLoc MAX Power-Injectable Infusion Set And SafeStep Huber Needle Set |
| Classification | Non-coring (huber) Needle |
| Applicant | C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Jeremy Tidwell |
| Correspondent | Jeremy Tidwell C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-06-12 |
| Decision Date | 2017-08-08 |
| Summary: | summary |