Cleared Special

K993694 - MIKRO-TIP ANGIOGRAPHIC CATHETER

K993694 is an FDA 510(k) clearance for MIKRO-TIP ANGIOGRAPHIC CATHETER, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with 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.

FDA 510(k) Submission Details - K993694

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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 489
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K993694.
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · Cordis Corp. · May 2000
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
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · Acuson Corp. · Dec 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
K993694 · MIKRO-TIP ANGIOGRAPHIC CATHETER
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