Cleared Traditional

K981936 - ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION

K981936 is an FDA 510(k) clearance for ABD VARISOFT STEERABLE GUIDE WIRE AND A..., manufactured by Advanced Biomedical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K981936 · Advanced Biomedical Devices, Inc. · Cardiovascular device
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Feb 2000
Decision
624d
Days
Class 2
Risk

K981936 is an FDA 510(k) clearance for the ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Biomedical Devices, Inc. (Andover, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Advanced Biomedical Devices, Inc. devices

FDA 510(k) Submission Details - K981936

510(k) Number K981936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1998
Decision Date February 16, 2000
Days to Decision 624 days
Submission Type Traditional
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
499d slower than avg
Panel avg: 125d · This submission: 624d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 663
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K981936.
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198 · Datascope Corp. · May 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · Cordis Neurovascular, Inc. · Apr 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011 · Lake Region Mfg., Inc. · Mar 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp. · Jan 2000
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · C.R. Bard, Inc. · Nov 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · Advanced Cardiovascular Systems, Inc. · Oct 1999