Cleared Traditional

K033389 - POWERPICC CATHETERS, MODELS 3175155, 3175135

K033389 is an FDA 510(k) clearance for POWERPICC CATHETERS, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K033389

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.

LJS Device Classification - Class 2, Special Controls

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 256
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