Cleared Traditional

K960098 - RMI INTERNAL MAMMARY ARTERY CANNULA

K960098 is the FDA 510(k) clearance for RMI INTERNAL MAMMARY ARTERY CANNULA by Research Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K960098 · Research Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
75d
Days
Class 2
Risk

K960098 is an FDA 510(k) clearance for the RMI INTERNAL MAMMARY ARTERY CANNULA. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on March 26, 1996 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Research Medical, Inc. devices

Submission Details

510(k) Number K960098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date March 26, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K960098.
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