The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerglide Pro Midline Catheter.
| Device ID | K153280 |
| 510k Number | K153280 |
| Device Name: | PowerGlide Pro Midline Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Casey Coombs |
| Correspondent | Casey Coombs C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-06-02 |
| Summary: | summary |