Cleared Special

K030255 - SILICONE DUAL LUMEN RADPICC CATHETERS

K030255 is the FDA 510(k) clearance for SILICONE DUAL LUMEN RADPICC CATHETERS by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Special 510(k) pathway after a 14-day FDA review.

K030255 · C.R. Bard, Inc. · General Hospital
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Feb 2003
Decision
14d
Days
Class 2
Risk

K030255 is an FDA 510(k) clearance for the SILICONE DUAL LUMEN RADPICC CATHETERS. 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 City, US). The FDA issued a Cleared decision on February 7, 2003 after a review of 14 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. devices

Submission Details

510(k) Number K030255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date February 07, 2003
Days to Decision 14 days
Submission Type Special
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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 180
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K030255.
POLY PER-Q-CATH PICC CATHETERS
K031129 · C.R. Bard, Inc. · May 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K030415 · AngioDynamics, Inc. · Apr 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
K030270 · Medcomp · Apr 2003
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374 · C.R. Bard, Inc. · Dec 2002
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc. · Sep 2001
CENTRAL VENOUS CATHETER
K003839 · Boston Scientific Corp · Aug 2001