Cleared Traditional

K162441 - PowerPICC Provena Catheters with SOLO V...

K162441 is an FDA 510(k) clearance for PowerPICC Provena Catheters with SOLO V..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K162441 · C.R. Bard, Inc. · General Hospital
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Apr 2017
Decision
236d
Days
Class 2
Risk

K162441 is an FDA 510(k) clearance for the PowerPICC Provena Catheters with SOLO Valve Technology. 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 April 24, 2017 after a review of 236 days - an extended review cycle.

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

FDA 510(k) Submission Details - K162441

510(k) Number K162441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2016
Decision Date April 24, 2017
Days to Decision 236 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
107d slower than avg
Panel avg: 129d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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 207
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K162441.
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994 · Cook Incorporated · Feb 2018
HydroPICC
K172885 · Access Vascular, Inc. · Feb 2018
Sherlock 3CG Tip Positioning System Stylet
K172397 · C.R. Bard, Inc. · Sep 2017
PICC Maximal Barrier Nursing Kit
K163452 · Navilyst Medical, Inc. · Feb 2017
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
Turbo-Flo PICC Sets
K161496 · Cook Incorporated · Oct 2016