Cleared Traditional

K803270 - GANZ CORONARY REPERFUSION CATHETER

K803270 is the FDA 510(k) clearance for GANZ CORONARY REPERFUSION CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K803270 · American Edwards Laboratories · Cardiovascular device

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Mar 1981

Decision

88d

Days

Class 2

Risk

K803270 is an FDA 510(k) clearance for the GANZ CORONARY REPERFUSION CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Edwards Laboratories devices

Submission Details

510(k) Number	K803270 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 1980
Decision Date	March 27, 1981
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

37d faster than avg

Panel avg: 125d · This submission: 88d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DQO Catheter, Intravascular, Diagnostic
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1200

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 291

Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K803270.

ANGIOGRAPHIC CATHETER

K821816 · Medi-Tech, Inc. · Aug 1982

ANGIOGRAPHY KIT

K821976 · Mallinckrodt Critical Care · Jul 1982

CORONARY INFUSION KIT

K820001 · Mallinckrodt Critical Care · Jan 1982

BAIM TM CORONARY SINUS FLOW THERMAL

K810360 · Electro-Catheter Corp. · Mar 1981

USCI CARDIOVASCULAR CATHETER

K810412 · C.R. Bard, Inc. · Mar 1981

PRESSURE MONITORING SET

K802945 · Norton Performance Plastics Corp. · Dec 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K803270

American Edwards Laboratories

Mchenry, IL · US

Regulatory profile

89 submissions 88 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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