Cleared Traditional

K033389 - POWERPICC CATHETERS

K033389 is the FDA 510(k) clearance for POWERPICC CATHETERS by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K033389 · C.R. Bard, Inc. · General Hospital
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Mar 2004
Decision
148d
Days
Class 2
Risk

K033389 is an FDA 510(k) clearance for the POWERPICC CATHETERS, MODELS 3175155, 3175135. 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 March 19, 2004 after a review of 148 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K033389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date March 19, 2004
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K033389.
PREMICATH, 1261.205
K041468 · Vygon Corp. · Sep 2004
PICC
K042126 · Arrow Intl., Inc. · Aug 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K041420 · AngioDynamics, Inc. · Jul 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
GROSHONG NXT PICC CATHETERS
K034020 · C.R. Bard, Inc. · Jan 2004