Cleared Abbreviated

K023374 - GROSHONG NXT DUAL LUMEN PICC CATHETERS

K023374 is the FDA 510(k) clearance for GROSHONG NXT DUAL LUMEN PICC CATHETERS by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K023374 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
71d
Days
Class 2
Risk

K023374 is an FDA 510(k) clearance for the GROSHONG NXT DUAL LUMEN PICC 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 December 18, 2002 after a review of 71 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K023374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date December 18, 2002
Days to Decision 71 days
Submission Type Abbreviated
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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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 K023374.
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
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255 · C.R. Bard, Inc. · Feb 2003
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
MEDCOMP Z-CATH
K003682 · Medical Components, Inc. · Jan 2001