Cleared Traditional

K893474 - BARD CATH LAB THERMODILUTION CATHETER

K893474 is an FDA 510(k) clearance for BARD CATH LAB THERMODILUTION CATHETER, 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 124-day FDA review.

K893474 · C.R. Bard, Inc. · Cardiovascular device
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Sep 1989
Decision
124d
Days
Class 2
Risk

K893474 is an FDA 510(k) clearance for the BARD CATH LAB THERMODILUTION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 124 days - within the typical 510(k) review window.

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 - K893474

510(k) Number K893474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date September 05, 1989
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
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 K893474.
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · Baxter Healthcare Corp · Feb 1990
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · Arrow Intl., Inc. · Sep 1989
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
K883948 · NuMED, Inc. · Apr 1989
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · Abbott Laboratories · May 1988
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · Medtronic Vascular · Nov 1987