Cleared Traditional

RMI FEMORAL VENOUS DRAINAGE CANNULA (K863740) - FDA 510(k) Clearance

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

K863740 · Research Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
149d
Days
Class 2
Risk

K863740 is an FDA 510(k) clearance for the RMI FEMORAL VENOUS DRAINAGE CANNULA. 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 February 19, 1987 after a review of 149 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 K863740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date February 19, 1987
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
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 K863740.
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