Cleared Traditional

K850952 - BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI

K850952 is an FDA 510(k) clearance for BARD CRITICAL CARE THERMODILUTIN CATHET..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K850952 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1985
Decision
151d
Days
Class 2
Risk

K850952 is an FDA 510(k) clearance for the BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 151 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K850952

510(k) Number K850952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date August 05, 1985
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K850952.
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · Medtronic Vascular · Nov 1987
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119 · Parke-Davis Co. · Aug 1986
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
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