The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerglide Midline Catheter.
Device ID | K121073 |
510k Number | K121073 |
Device Name: | POWERGLIDE 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 | Jessica Agnello |
Correspondent | Jessica Agnello 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 | 2012-04-09 |
Decision Date | 2012-06-01 |
Summary: | summary |