Cleared Special

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

K222232 · Bard Access Systems, Inc. · General Hospital
Aug 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K222232 is an FDA 510(k) clearance for the Sherlock 3CG? Tip Positioning System (TPS) Stylet/T-Lock Assembly, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on August 24, 2022, 30 days after receiving the submission on July 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K222232 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date August 24, 2022
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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