Cleared Special

K034020 - GROSHONG NXT PICC CATHETERS

K034020 is the FDA 510(k) clearance for GROSHONG NXT PICC 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 28-day FDA review.

K034020 · C.R. Bard, Inc. · General Hospital
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Jan 2004
Decision
28d
Days
Class 2
Risk

K034020 is an FDA 510(k) clearance for the GROSHONG NXT 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 January 21, 2004 after a review of 28 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 K034020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date January 21, 2004
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 K034020.
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · C.R. Bard, Inc. · Mar 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K040446 · AngioDynamics, Inc. · Mar 2004
POLY PER-Q-CATH PICC CATHETERS
K034019 · C.R. Bard, Inc. · Jan 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626 · AngioDynamics, Inc. · Jun 2003
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