Cleared Traditional

K980973 - MEDTRONIC ANGIOGRAPHIC CATHETER

K980973 is an FDA 510(k) clearance for MEDTRONIC ANGIOGRAPHIC CATHETER, manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K980973 · Medtronics Interventional Vascular · Cardiovascular device
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Dec 1998
Decision
269d
Days
Class 2
Risk

K980973 is an FDA 510(k) clearance for the MEDTRONIC ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on December 10, 1998 after a review of 269 days - an extended review 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: 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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K980973

510(k) Number K980973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date December 10, 1998
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
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 351
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K980973.
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K992123 · Boston Scientific Scimed, Inc. · Aug 1999
RADIFOCUS OPTITORQUE
K992051 · Terumo Medical Corp. · Aug 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · Daig Corp. · Oct 1998
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · Scimed Life Systems, Inc. · Aug 1998