Cleared Traditional

K860136 - BARD-PARKER CAROTID SHUNT

K860136 is an FDA 510(k) clearance for BARD-PARKER CAROTID SHUNT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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Jun 1986
Decision
162d
Days
Class 2
Risk

K860136 is an FDA 510(k) clearance for the BARD-PARKER CAROTID SHUNT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 25, 1986 after a review of 162 days - an extended review cycle.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K860136

510(k) Number K860136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date June 25, 1986
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K860136.
URESIL CAROTID SHUNT
K863558 · Uresil Corp. · Nov 1986
TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT
K862634 · Research Medical, Inc. · Oct 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · Research Medical, Inc. · Jul 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