Cleared Special

K180548 - 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers (FDA 510(k) Clearance)

Also includes:
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180548 · C.R. Bard, Inc (Bard Has Joined Bd) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
56d
Days
Class 2
Risk

K180548 is an FDA 510(k) clearance for the 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by C.R. Bard, Inc (Bard Has Joined Bd) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 26, 2018 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc (Bard Has Joined Bd) devices

Submission Details

510(k) Number K180548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date April 26, 2018
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 301
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K180548.
Neonav ECG Tip Location System
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K252792 · Piccolo Medical, Inc. · Nov 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)
K243458 · Access Vascular, Inc. · Aug 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025