Cleared Traditional

K860743 - CAROTID BYPASS SHUNT WITH SAMPLING ARM

K860743 is the FDA 510(k) clearance for CAROTID BYPASS SHUNT WITH SAMPLING ARM by Clincal Instruments Corp.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K860743 · Clincal Instruments Corp. · Cardiovascular device
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May 1986
Decision
90d
Days
Class 2
Risk

K860743 is an FDA 510(k) clearance for the CAROTID BYPASS SHUNT WITH SAMPLING ARM. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Clincal Instruments Corp. (Dudley, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Clincal Instruments Corp. devices

Submission Details

510(k) Number K860743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1986
Decision Date May 28, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 232
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K860743.
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986
RMI POROUS VENT PLUG
K861322 · Research Medical, Inc. · May 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · Gish Biomedical, Inc. · May 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · Shiley, Inc. · May 1986
RMI CAROTID BY-PASS SHUNT
K860988 · Research Medical, Inc. · May 1986