Cleared Special

K000579 - TEMPO AQUA ANGIOGRAPHIC CATHETER

K000579 is an FDA 510(k) clearance for TEMPO AQUA ANGIOGRAPHIC CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 71-day FDA review.

K000579 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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May 2000
Decision
71d
Days
Class 2
Risk

K000579 is an FDA 510(k) clearance for the TEMPO AQUA ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 71 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K000579

510(k) Number K000579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date May 03, 2000
Days to Decision 71 days
Submission Type Special
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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 K000579.
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MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · Boston Scientific Scimed, Inc. · Apr 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · Merit Medical Systems, Inc. · Mar 2000
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173 · Maxxim Medical · Dec 1999