The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerpicc Sv Catheters.
Device ID | K102159 |
510k Number | K102159 |
Device Name: | POWERPICC SV CATHETERS |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-02 |
Decision Date | 2010-11-17 |
Summary: | summary |