Cleared Traditional

K862634 - TDMAC-HEPARIN COATED RMI CAROTID BY-PAS...

K862634 is an FDA 510(k) clearance for TDMAC-HEPARIN COATED RMI CAROTID BY-PAS..., manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K862634 · Research Medical, Inc. · Cardiovascular device
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Oct 1986
Decision
113d
Days
Class 2
Risk

K862634 is an FDA 510(k) clearance for the TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1986 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 870.4210 - 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K862634

510(k) Number K862634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date October 31, 1986
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 270
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K862634.
ASPIRATING NEEDLE, CATALOG CODE #12006
K865079 · Dlp, Inc. · Mar 1987
RMI FEMORAL VENOUS DRAINAGE CANNULA
K863740 · Research Medical, Inc. · Feb 1987
URESIL CAROTID SHUNT
K863558 · Uresil Corp. · Nov 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · Research Medical, Inc. · Jul 1986
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986