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Blazer® II XP M0044770TK10

by Boston Scientific

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number08714729144335 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0202-2019 FDA Class II initiated 20 Jun 2018

    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Blazer® II XP
Generic Name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
M0044770TK10
Primary DI / UDI-DI
08714729144335
PMA Number
FDA Product Code
OAD
GMDN Term
Cardiac radio-frequency ablation system catheter
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac radio-frequency ablation system catheter

Cleared under the same submission (P020025)

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