Cleared Traditional

K081187 - BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001

K081187 is an FDA 510(k) clearance for BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS..., manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K081187 · Bridgepoint Medical · Cardiovascular device
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Oct 2008
Decision
163d
Days
Class 2
Risk

K081187 is an FDA 510(k) clearance for the BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MO.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Bridgepoint Medical (Orinda, US). The FDA issued a Cleared decision on October 8, 2008 after a review of 163 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 Bridgepoint Medical devices

FDA 510(k) Submission Details - K081187

510(k) Number K081187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date October 08, 2008
Days to Decision 163 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
38d slower than avg
Panel avg: 125d · This submission: 163d
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 607
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K081187.
FREEWAY AND RAILRUNNER GUIDEWIRES
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VISION WIRE CORONARY GUIDEWIRE
K082935 · Biotronik, Inc. · Dec 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · Asahi Intecc Co., Ltd. · Nov 2008
ROLL-X GUIDEWIRE
K082304 · St Jude Medical · Aug 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · Stereotaxis, Inc. · Aug 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp · Aug 2008