Cleared Special

K091841 - BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000

K091841 is an FDA 510(k) clearance for BRIDGEPOINT MEDICAL CROSSBOSS 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 72-day FDA review.

K091841 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
72d
Days
Class 2
Risk

K091841 is an FDA 510(k) clearance for the BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bridgepoint Medical (Plymouth, US). The FDA issued a Cleared decision on September 2, 2009 after a review of 72 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 - K091841

510(k) Number K091841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2009
Decision Date September 02, 2009
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 K091841.
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K090918 · Nfocus Neuromedical, Inc. · Jul 2009
K091841 · BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
Download PDF FDA Summary Bridgepoint Medical