Cleared Traditional

K961552 - CVP POLYURETHANE CATHETER

K961552 is an FDA 510(k) clearance for CVP POLYURETHANE CATHETER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K961552 · Abbott Laboratories · General Hospital
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Feb 1997
Decision
294d
Days
Class 2
Risk

K961552 is an FDA 510(k) clearance for the CVP POLYURETHANE CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 294 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K961552

510(k) Number K961552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date February 10, 1997
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K961552.
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V-CATH
K964966 · Hdc Corp. · Mar 1997
FIRST MIDCATH CATHETER KIT
K964048 · Becton Dickinson Vascular Access, Inc. · Jan 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049 · Becton Dickinson Vascular Access, Inc. · Jan 1997
FIRST MIDCATH CATHETER
K964050 · Becton Dickinson Vascular Access, Inc. · Jan 1997