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MAGiC Sweep 181019

by Access Point Technologies, Inc.

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 Number00818087023054 UDI-DI Date15 May 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  • Withdrawn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 Sweep
Generic Name
Cardiac mapping catheter, percutaneous, single-use
Model / Ref / Catalog
181019
Primary DI / UDI-DI
00818087023054
510(k) Number
FDA Product Code
DRF
GMDN Term
Cardiac mapping catheter, percutaneous, single-use
Device Class
Class II
Regulation Number
870.1220
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8 French
Length — 130 Centimeter

Related devices

Cleared under the same submission (K250590)

Other devices from Access Point Technologies, Ep Inc.

See all devices from Access Point Technologies, Ep Inc. →

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