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DiamondTemp™ Unidirectional Ablation Catheter CEDT100S

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 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 Number00763000482107 UDI-DI Date21 Oct 2021ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1320-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1318-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1317-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1322-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1319-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1321-2021 FDA Class II initiated 22 Feb 2021

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DiamondTemp™ Unidirectional Ablation Catheter
Generic Name
Cardiac radio-frequency ablation system catheter
Model / Reference
CEDT100S
Primary DI / UDI-DI
00763000482107
PMA Number
FDA Product Code
OAE
GMDN Term
Cardiac radio-frequency ablation system catheter
Device Class
Class III
GUDID distribution status
In Commercial Distribution
Size
Catheter Length — 110.0 Centimeter
Tip Bend Radius — 45.0 Millimeter
Outer Diameter — 2.67 Millimeter

Related devices

Cleared under the same submission (P200028)

Show all (12)

Other devices from Medtronic, Inc.

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Properties

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

Other properties (10)

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