FDA.reportPublic FDA data

MAGiC Sweep

Primary DI
00818087022873
Brand
MAGiC Sweep
Company
ACCESS POINT TECHNOLOGIES, INC.
Model
181001
Catalog number
181001
Device description
MAGiC Sweep, 5/8F, 2-2-2mm, 13-5-0-5-5mm, 130cm
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250590000MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.2025-07-23DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818087022873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818087022873008180870228738180870228730818087022873

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length130Centimeter

Regulatory Flags#

DUNS number
128599565
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818087022880MAGiC Sweep1810021810022026-05-15
00818087022897MAGiC Sweep1810031810032026-05-15
00818087023054MAGiC Sweep1810191810192026-05-15
00818087023061MAGiC Sweep1810201810202026-05-15
00818087023085MAGiC Sweep1810221810222026-05-15
00818083014001Map-iT9033079033072019-06-25
00818083015909Map-iT9036029036022019-06-25
00818083015947Map-iT9036069036062019-06-25
00818083015954Map-iT9036079036072019-06-25
00818083015961Map-iT9036089036082019-06-25
00818083015978Map-iT9036099036092019-06-25
00818083015985Map-iT9036109036102019-06-25
00818083016005Map-iT9036129036122019-06-25
00818083016036Map-iT9036159036152019-06-25
00818083016050Map-iT9036179036172019-06-25
00818083016067Map-iT9036189036182019-06-25
00818083016074Map-iT9036199036192019-06-25
00818083016081Map-iT9036209036202019-06-25
00818083016258Map-iT9037009037002019-06-25
00818083016265Map-iT9037019037012019-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
05414734202701Livewire™ST. JUDE MEDICAL, INC.DRF2023-10-31
00763000445720NAMEDTRONIC, INC.DRF2023-03-18
10801902198379ARROWTELEFLEX INCORPORATEDDRF2022-11-17
10801902198348ARROWTELEFLEX INCORPORATEDDRF2022-10-28
10801902198256ARROWTELEFLEX INCORPORATEDDRF2022-10-21
10801902198317ARROWTELEFLEX INCORPORATEDDRF2022-10-17
10846835018080nGEN GeneratorBiosense Webster IncDRF2022-08-18
10801902211481ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902211504ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902198300ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198409ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198393ARROWTELEFLEX INCORPORATEDDRF2022-05-11
10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25
00643169778184NAMEDTRONIC, INC.DRF2016-11-04
08714729082002SteeroCath-Dx™BOSTON SCIENTIFIC CORPORATIONDRF2016-09-24