Cleared Traditional

K061179 - POWERHICKMAN LONG-TERM INTRAVASCULAR CA...

K061179 is the FDA 510(k) clearance for POWERHICKMAN LONG-TERM INTRAVASCULAR CA... 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 104-day FDA review.

K061179 · C.R. Bard, Inc. · General Hospital
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Aug 2006
Decision
104d
Days
Class 2
Risk

K061179 is an FDA 510(k) clearance for the POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER. 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 August 9, 2006 after a review of 104 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 K061179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date August 09, 2006
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 K061179.
POWERGROSHONG PICC CATHETER
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K062425 · Vygon Corp. · Sep 2006
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K061986 · Medcomp · Aug 2006
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K060887 · AngioDynamics, Inc. · Apr 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345 · Medcomp · Mar 2006