Cleared Traditional

K080987 - BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES

K080987 is an FDA 510(k) clearance for BRIDGEPOINT MEDICAL STINGRAY DEVICE AND..., 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 305-day FDA review.

K080987 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
305d
Days
Class 2
Risk

K080987 is an FDA 510(k) clearance for the BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bridgepoint Medical (Orinda, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 305 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.

FDA 510(k) Submission Details - K080987

510(k) Number K080987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date February 06, 2009
Days to Decision 305 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
180d slower than avg
Panel avg: 125d · This submission: 305d
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 861
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K080987 · BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
Download PDF FDA Summary Bridgepoint Medical