The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sherlock Tip Location System (tls).
Device ID | K060341 |
510k Number | K060341 |
Device Name: | SHERLOCK TIP LOCATION SYSTEM (TLS) |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less 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 | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-10 |
Decision Date | 2006-04-14 |
Summary: | summary |