Cleared Traditional

BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE (K862937) - FDA 510(k) Clearance

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

K862937 · Versaflex Delivery Systems, Inc. · Cardiovascular device
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Sep 1986
Decision
51d
Days
Class 2
Risk

K862937 is an FDA 510(k) clearance for the BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Versaflex Delivery Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Versaflex Delivery Systems, Inc. devices

Submission Details

510(k) Number K862937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1986
Decision Date September 24, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K862937.
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
TERUMO RADIFOCUS GUIDE WIRE
K863138 · Terumo Medical Corp. · Nov 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · Shiley, Inc. · Jun 1986
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983