Cleared Traditional

RSI FEMORAL GUIDING CATHETER (K902943) - FDA 510(k) Clearance

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

K902943 · Retroperfusion Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
90d
Days
Class 2
Risk

K902943 is an FDA 510(k) clearance for the RSI FEMORAL GUIDING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Retroperfusion Systems, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 3, 1990 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 870.1200 - 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 Retroperfusion Systems, Inc. devices

Submission Details

510(k) Number K902943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date October 03, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K902943.
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · C.R. Bard, Inc. · Feb 1991
MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · C.R. Bard, Inc. · Apr 1990
SONICATH(TM) 5 F
K895542 · Boston Scientific Corp · Apr 1990
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990