Cleared Traditional

K863137 - TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER

K863137 is an FDA 510(k) clearance for TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K863137 · Terumo Medical Corp. · Cardiovascular device
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Oct 1986
Decision
56d
Days
Class 2
Risk

K863137 is an FDA 510(k) clearance for the TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on October 10, 1986 after a review of 56 days - a notably fast clearance cycle.

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: 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K863137

510(k) Number K863137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date October 10, 1986
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K863137.
NUMED BALLOON WEDGE PRESSURE CATHETER
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NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · NuMED, Inc. · Feb 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · Medtronic Vascular · Sep 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · Shiley, Inc. · Aug 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464 · Shiley, Inc. · Aug 1986