The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sherlock Tls Stylet, Sherlock Tls Detector.
Device ID | K063240 |
510k Number | K063240 |
Device Name: | SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR |
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 | Lynn M Kirchoff |
Correspondent | Lynn M Kirchoff 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 | 2006-10-26 |
Decision Date | 2006-11-21 |
Summary: | summary |