Cleared Traditional

K853383 - CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN

K853383 is an FDA 510(k) clearance for CARDIOVASCULAR, manufactured by Webster Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K853383 · Webster Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
113d
Days
Class 2
Risk

K853383 is an FDA 510(k) clearance for the CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Webster Laboratories, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 113 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 Webster Laboratories, Inc. devices

FDA 510(k) Submission Details - K853383

510(k) Number K853383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date December 03, 1985
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
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 72
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K853383.
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · Abbott Laboratories · May 1988
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
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952 · C.R. Bard, Inc. · Aug 1985
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985