Cleared Traditional

K894243 - RMI ARTERIAL PERFUSION CANNULA

K894243 is an FDA 510(k) clearance for RMI ARTERIAL PERFUSION CANNULA, manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K894243 · Research Medical, Inc. · Cardiovascular device
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Sep 1989
Decision
90d
Days
Class 2
Risk

K894243 is an FDA 510(k) clearance for the RMI ARTERIAL PERFUSION CANNULA. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 - K894243

510(k) Number K894243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date September 19, 1989
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQR Device Classification - Class 2, Special Controls

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 14
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K894243.
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · Research Medical, Inc. · Mar 1996
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · Datascope Corp. · Jan 1991
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · Argon Medical Corp. · Jan 1989
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · Medsurg Industries, Inc. · May 1988