Cleared Traditional

K841876 - POLYURETHANE THERMAL DILUTION CATHET

K841876 is an FDA 510(k) clearance for POLYURETHANE THERMAL DILUTION CATHET, manufactured by Waters Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K841876 · Waters Instruments, Inc. · Cardiovascular device
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Jul 1984
Decision
67d
Days
Class 2
Risk

K841876 is an FDA 510(k) clearance for the POLYURETHANE THERMAL DILUTION CATHET. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Waters Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 67 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 Waters Instruments, Inc. devices

FDA 510(k) Submission Details - K841876

510(k) Number K841876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date July 13, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
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 K841876.
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985
FLOW-DIRECTED THERMODILUTION CATH
K843409 · Andover Medical, Inc. · Oct 1984
THERMAL DILUTION CATHETER
K843411 · Andover Medical, Inc. · Oct 1984
DESERET HEPARIN COATED FLOW CATH
K841251 · Parke-Davis Co. · Jun 1984
DESERET HEPARIN COATED FLOW DIRECTED
K841317 · Parke-Davis Co. · Jun 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984