The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Silicone Dual Lumen Radpicc Catheters.
Device ID | K030255 |
510k Number | K030255 |
Device Name: | SILICONE DUAL LUMEN RADPICC CATHETERS |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Contact | Peggy Keiffer |
Correspondent | Peggy Keiffer C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-24 |
Decision Date | 2003-02-07 |
Summary: | summary |