Cleared Traditional

K933334 - MAGIC TORQUE GUIDEWIRE

K933334 is an FDA 510(k) clearance for MAGIC TORQUE GUIDEWIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K933334 · Boston Scientific Corp · Cardiovascular device
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Jan 1994
Decision
202d
Days
Class 2
Risk

K933334 is an FDA 510(k) clearance for the MAGIC TORQUE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 202 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K933334

510(k) Number K933334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1993
Decision Date January 26, 1994
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K933334.
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · Scimed Life Systems, Inc. · Mar 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982 · Cordis Corp. · Feb 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · Scimed Life Systems, Inc. · Feb 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · Scimed Life Systems, Inc. · Jan 1994
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
K934602 · Advanced Cardiovascular Systems, Inc. · Dec 1993
LOC GUIDE WIRE EXTENSION
K934339 · Advanced Cardiovascular Systems, Inc. · Dec 1993