Atlas FDA

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

FDA 510(k) clearance K222232 · decided 2022-08-24

Clearance details

K-number
K222232
Device name
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
Applicant
Bard Access Systems, Inc.
Decision
Substantially Equivalent
Date received
2022-07-25
Decision date
2022-08-24
Days to decision
30 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake Ciy,, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.