Cleared Traditional

K812563 - SWAN-GANZ & EDSLAB HEPARIN COATED CATH.

K812563 is the FDA 510(k) clearance for SWAN-GANZ & EDSLAB HEPARIN COATED CATH. by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812563 · American Edwards Laboratories · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Sep 1981

Decision

17d

Days

Class 2

Risk

K812563 is an FDA 510(k) clearance for the SWAN-GANZ & EDSLAB HEPARIN COATED CATH.. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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	K812563 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1981
Decision Date	September 25, 1981
Days to Decision	17 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

108d faster than avg

Panel avg: 125d · This submission: 17d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DYG Catheter, Flow Directed
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1240

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 - DYG Catheter, Flow Directed

All 53

Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K812563.

SWAN-GANZ VIP-CATHETER

K820222 · American Edwards Laboratories · Feb 1982

NORTON FLOW DIRECTED THERMODILUTION CATH

K820229 · Norton Performance Plastics Corp. · Feb 1982

FLOW-DIRECTED THERMODILUTION CATHETER

K812324 · Sorensen Research · Sep 1981

SWAN-GANZ FLOW-DIRECTED THERMODILUTION

K810352 · American Edwards Laboratories · Mar 1981

SWAN-GANZ VIP THERMODILUTION CATHETER

K810124 · American Edwards Laboratories · Feb 1981

TORQUE CONTROL BALLOON CATHETER

K802338 · Cordis Corp. · Oct 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 K812563

American Edwards Laboratories

Mchenry, IL · US

Regulatory profile

89 submissions 88 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active