Cleared Traditional

PIOLAX HYDROPHILIC GUIDEWIRE (K980977) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980977 · Piolax Medical Devices, Inc. · Cardiovascular device
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Oct 1998
Decision
225d
Days
Class 2
Risk

K980977 is an FDA 510(k) clearance for the PIOLAX HYDROPHILIC GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Piolax Medical Devices, Inc. (Washington, US). The FDA issued a Cleared decision on October 27, 1998 after a review of 225 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Piolax Medical Devices, Inc. devices

Submission Details

510(k) Number K980977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date October 27, 1998
Days to Decision 225 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 125d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K980977.
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · C.R. Bard, Inc. · Nov 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999
STRATEGY CORONARY WIRE GUIDE
K983771 · Cook, Inc. · Nov 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · C.R. Bard, Inc. · Oct 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560 · Cordis Corp. · May 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · Cordis Corp. · Jan 1998