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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K061171.
TREASURE
K061984 · Asahi Intecc Co., Ltd. · Oct 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · Guidant Corp. · Jun 2006
BRIVANT GUIDEWIRE
K060551 · Brivant Limited · Jun 2006
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
K060449 · Guidant Corporation · May 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · Micrus Endovascular Corporation · Apr 2006
AMPLATZER NOODLEWIRE GUIDEWIRE
K053187 · Aga Medical Corp. · Apr 2006
K061171 · SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
Download PDF FDA Summary Biosphere Medical, In…