Cleared Traditional

K870421 - TDMAC-HEPARIN COATED RMI

K870421 is an FDA 510(k) clearance for TDMAC-HEPARIN COATED RMI, 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 108-day FDA review.

K870421 · Research Medical, Inc. · Cardiovascular device
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May 1987
Decision
108d
Days
Class 2
Risk

K870421 is an FDA 510(k) clearance for the TDMAC-HEPARIN COATED RMI. 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 May 22, 1987 after a review of 108 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 - K870421

510(k) Number K870421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date May 22, 1987
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K870421.
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · Uresil Corp. · Sep 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987
ARGYLE VASCULAR BYPASS SET
K871844 · Sherwood Medical Co. · Aug 1987
RMI VENOUS DRAINAGE CANNULA
K870109 · Research Medical, Inc. · Mar 1987
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
K870507 · Research Medical, Inc. · Mar 1987
ASPIRATING NEEDLE, CATALOG CODE #12006
K865079 · Dlp, Inc. · Mar 1987