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Mantaray Guidewires

by Bridgepoint Medical 510(k)

Active United States

510(k) K120881

Overview

The Mantaray Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). They are designed to navigate stenotic peripheral lesions, including chronic total occlusions.

The Mantaray Guidewires are single-use, disposable percutaneous devices. They are classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls, and received FDA 510(k) clearance with number K120881 on April 18, 2012.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120881 Date18 Apr 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the intended use of Mantaray Guidewires?

    Mantaray Guidewires are designed to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). They specifically help navigate stenotic peripheral lesions, including chronic total occlusions.

  • Are Mantaray Guidewires single-use or reusable devices?

    Mantaray Guidewires are single-use, disposable percutaneous devices. They are not intended for reuse and should be discarded after a single procedure to ensure patient safety and device performance.

  • What regulatory clearance do Mantaray Guidewires have?

    Mantaray Guidewires received FDA 510(k) clearance with number K120881 on April 18, 2012. They are classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

  • What sizes and models of Mantaray Guidewires are available?

    The device data does not specify available sizes or models of Mantaray Guidewires. For detailed information regarding available configurations, please consult the manufacturer directly or refer to the product documentation.