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MAGiC Magnetic Interventional Ablation Catheter 8C-21-031Z-B

by Osypka AG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04044508152225 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MAGiC Magnetic Interventional Ablation Catheter
Generic Name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
8C-21-031Z-B, 001-009740-2
Primary DI / UDI-DI
04044508152225
PMA Number
FDA Product Code
LPB
GMDN Term
Cardiac radio-frequency ablation system catheter
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 2.8 Millimeter

Related devices

Cleared under the same submission (P240014)

Other devices from Osypka AG

See all devices from Osypka AG →

Properties

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

Other properties (8)

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