Cleared Traditional

K061171 - SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

K061171 is an FDA 510(k) clearance for SEQUITOR STEERABLE GUIDEWIRE, manufactured by Biosphere Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K061171 · Biosphere Medical, Inc. · Cardiovascular device
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Jun 2006
Decision
36d
Days
Class 2
Risk

K061171 is an FDA 510(k) clearance for the SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biosphere Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 2, 2006 after a review of 36 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 Biosphere Medical, Inc. devices

FDA 510(k) Submission Details - K061171

510(k) Number K061171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date June 02, 2006
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 616
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K061171.
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · Asahi Intecc Co., Ltd. · Nov 2006
TREASURE
K061984 · Asahi Intecc Co., Ltd. · Oct 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · Guidant Corp. · Jun 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · Micrus Endovascular Corporation · Apr 2006
TITAN GUIDEWIRE
K060454 · Lake Region Mfg., Inc. · Mar 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · Lake Region Mfg., Inc. · Feb 2006