Cleared Traditional

K771043 - SWAN GANZ

K771043 is the FDA 510(k) clearance for SWAN GANZ by Clincal Instruments Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 54
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