Cleared Traditional

K771043 - SWAN GANZ

K771043 is an FDA 510(k) clearance for SWAN GANZ, manufactured by Clincal Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K771043 · Clincal Instruments Corp. · Cardiovascular device
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Dec 1977
Decision
194d
Days
Class 2
Risk

K771043 is an FDA 510(k) clearance for the SWAN GANZ. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Clincal Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Clincal Instruments Corp. devices

FDA 510(k) Submission Details - K771043

510(k) Number K771043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1977
Decision Date December 20, 1977
Days to Decision 194 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K771043.
TORQUE CONTROL BALLOON CATHETER
K802338 · Cordis Corp. · Oct 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · Cordis Corp. · Aug 1980
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · C.R. Bard, Inc. · Dec 1978
CATHETER, PACING/MONITORING
K772059 · Electro-Catheter Corp. · Nov 1977
CATHETER, GRUNTZIG, BALLON
K770522 · Cook, Inc. · Mar 1977
CATHETER, FLOW DIRECTED THERMAL DILUTION
K760533 · Gould, Inc. · Sep 1976