Cleared Traditional

K990173 - PATHFINDER II ANGIOGRAPHIC CATHETER

K990173 is an FDA 510(k) clearance for PATHFINDER II ANGIOGRAPHIC CATHETER, manufactured by Maxxim Medical. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K990173 · Maxxim Medical · Cardiovascular device
Download Printable Device Report (PDF)
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Dec 1999
Decision
336d
Days
Class 2
Risk

K990173 is an FDA 510(k) clearance for the PATHFINDER II ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Maxxim Medical (Athens, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Maxxim Medical devices

FDA 510(k) Submission Details - K990173

510(k) Number K990173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date December 21, 1999
Days to Decision 336 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
211d slower than avg
Panel avg: 125d · This submission: 336d
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 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K990173.
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
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · Acuson Corp. · Dec 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · Boston Scientific Scimed, Inc. · Aug 1999