Cleared Special

K111488 - MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003

K111488 is an FDA 510(k) clearance for MANTARAY GUIDEWIRE MODEL M-6000, manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 30-day FDA review.

K111488 · Bridgepoint Medical · Cardiovascular device
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Jun 2011
Decision
30d
Days
Class 2
Risk

K111488 is an FDA 510(k) clearance for the MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Bridgepoint Medical (Plymouth, US). The FDA issued a Cleared decision on June 30, 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 870.1330 - 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 - K111488

510(k) Number K111488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date June 30, 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.

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
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