Cleared Traditional

TDMAC-HEPARIN COATED RMI (K870421) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870421 · Research Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 122
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K870421.
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987
ARGYLE VASCULAR BYPASS SET
K871844 · Sherwood Medical Co. · Aug 1987
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · Shiley, Inc. · May 1986