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, Safestep Huber Needle Set.
| Device ID | K153440 |
| 510k Number | K153440 |
| Device Name: | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set |
| Classification | Set, Administration, Intravascular |
| Applicant | C.R BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Darlene Hull |
| Correspondent | Darlene Hull C.R BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-08-18 |
| Summary: | summary |