The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Groshong Nxt Dual Lumen Picc Catheters.
Device ID | K023374 |
510k Number | K023374 |
Device Name: | GROSHONG NXT DUAL LUMEN PICC 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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-08 |
Decision Date | 2002-12-18 |
Summary: | summary |