Cleared Traditional

Sherlock 3CG+ T ip Confirmation System (K180560) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180560 · C.R. Bard, Inc. · General Hospital
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Jun 2018
Decision
109d
Days
Class 2
Risk

K180560 is an FDA 510(k) clearance for the Sherlock 3CG+ T ip Confirmation System. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on June 18, 2018 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K180560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date June 18, 2018
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 95
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K180560.
HydroPICC (PICC-142)
K193015 · Access Vascular, Inc. · Feb 2020
Jet Power Injectable PICC
K180546 · Jet Medical, Inc. · Nov 2018
5 FR Dual Lumen Piper PICC
K181904 · Piper Access, LLC · Sep 2018
Biowy PlCC Catheter
K173956 · Biowy Corporation · May 2018
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
K180548 · C.R. Bard, Inc (Bard Has Joined Bd) · Apr 2018
Hickman TriFusion Catheter
K172511 · C.R. Bard, Inc. · Apr 2018