Cleared Special

K111963 - BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

K111963 is an FDA 510(k) clearance for BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER, manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K111963 · Bridgepoint Medical · Cardiovascular device
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Aug 2011
Decision
30d
Days
Class 2
Risk

K111963 is an FDA 510(k) clearance for the BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bridgepoint Medical (Plymouth, US). The FDA issued a Cleared decision on August 10, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bridgepoint Medical devices

FDA 510(k) Submission Details - K111963

510(k) Number K111963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date August 10, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K111963.
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