The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Bd Powerpicc Catheter.
Device ID | K210264 |
510k Number | K210264 |
Device Name: | BD PowerPiCC Catheter |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Mary Strickland |
Correspondent | Mary Strickland Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-01 |
Decision Date | 2021-07-30 |