Cleared Traditional

K832957 - FLOW-DIRECTED HEPARIN COATED THERMODIL

K832957 is the FDA 510(k) clearance for FLOW-DIRECTED HEPARIN COATED THERMODIL by Sorensen Research. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K832957 · Sorensen Research · Cardiovascular device
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Sep 1983
Decision
29d
Days
Class 2
Risk

K832957 is an FDA 510(k) clearance for the FLOW-DIRECTED HEPARIN COATED THERMODIL. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 29 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 Sorensen Research devices

Submission Details

510(k) Number K832957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1983
Decision Date September 29, 1983
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 40
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K832957.
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · American Edwards Laboratories · Oct 1982