Cleared Traditional

K081130 - BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER

K081130 is an FDA 510(k) clearance for BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANE..., manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K081130 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
388d
Days
Class 2
Risk

K081130 is an FDA 510(k) clearance for the BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bridgepoint Medical (Orinda, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Elevated predicate reliance profile. 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 - K081130

510(k) Number K081130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date May 14, 2009
Days to Decision 388 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
263d slower than avg
Panel avg: 125d · This submission: 388d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 659
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K081130.
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CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K090913 · Spectranetics Corp. · May 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
K090849 · Ev3, Inc. · May 2009