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Quantum™ Maverick™ H7493808112500

by Boston Scientific

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729393269 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

    • Terminated Z-2165-2008 FDA Unclassified (pre-2012) initiated 1 May 2007

    The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

    • Terminated Z-2166-2008 FDA Unclassified (pre-2012) initiated 1 Nov 2005

    Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.

  • 3 recalls, same reason

    • Terminated Z-0030-04 FDA Unclassified (pre-2012) initiated 20 Aug 2003
    • Terminated Z-0032-04 FDA Unclassified (pre-2012) initiated 20 Aug 2003
    • Terminated Z-0031-04 FDA Unclassified (pre-2012) initiated 20 Aug 2003

    Some of the recalled catheters have a component that has levels of pyrogens above specification.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Quantum™ Maverick™
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
H7493808112500
Primary DI / UDI-DI
08714729393269
PMA Number
FDA Product Code
LOX
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary angioplasty balloon catheter, basic

Cleared under the same submission (P860019)

Show all (12)

Other devices from Boston Scientific

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No