Cleared Special

K120129 - MANTARAY CATHETER

K120129 is an FDA 510(k) clearance for MANTARAY 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 17-day FDA review.

K120129 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
17d
Days
Class 2
Risk

K120129 is an FDA 510(k) clearance for the MANTARAY 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 February 3, 2012 after a review of 17 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.

FDA 510(k) Submission Details - K120129

510(k) Number K120129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date February 03, 2012
Days to Decision 17 days
Submission Type Special
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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K120129.
Q50 PLUS STENT GRAFT BALLOON CATHETER
K120381 · Qxmedical, LLC · Feb 2012
UPSTREAM SUPPORT CATHETER
K112886 · Upstream Peripheral Technologies · Feb 2012
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K120178 · Reflow Medical · Feb 2012
FUNNEL GUIDE CATHETER MODEL G1020608
K102439 · Lazarus Effect, Inc. · Jan 2012
VALET MICRO CATHETER
K112035 · Volcano Corporation · Jan 2012
BIGBOSS CATHETER
K113589 · Bridgepoint Medical · Jan 2012
K120129 · MANTARAY CATHETER
Download PDF FDA Summary Bridgepoint Medical