Cleared Special

K993694 - MIKRO-TIP ANGIOGRAPHIC CATHETER

K993694 is the FDA 510(k) clearance for MIKRO-TIP ANGIOGRAPHIC CATHETER by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 120-day FDA review.

K993694 · Millar Instruments, Inc. · Cardiovascular device
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Mar 2000
Decision
120d
Days
Class 2
Risk

K993694 is an FDA 510(k) clearance for the MIKRO-TIP ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 120 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Millar Instruments, Inc. devices

Submission Details

510(k) Number K993694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1999
Decision Date March 01, 2000
Days to Decision 120 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

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 266
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K993694.
GOLDEN-RULE SCALING CATHETER
K002416 · Medical Device Technologies, Inc. · Sep 2000
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K000579 · Cordis Corp. · May 2000
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K000659 · Merit Medical Systems, Inc. · Mar 2000
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
RADIFOCUS OPTITORQUE
K992051 · Terumo Medical Corp. · Aug 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999