Device
MAGiC Sweep, 5/8F, 2-2-2mm, 0-13-0-5-5mm, 130cm
Manufacturer
ACCESS POINT TECHNOLOGIES, INC.
ACCESS POINT TECHNOLOGIES, INC.
Model: 181003
Catalog: 181003
DI: 00818087022897
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
MAGiC Sweep, 5/8F, 2-2-2mm, 0-13-0-5-5mm, 130cm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
431e226a-cdbe-493b-b53a-b8ec14233f9b
Distribution Status:
In Commercial Distribution
DUNS Number:
128599565
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00818087022897
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46355
Name: Cardiac mapping catheter, percutaneous, single-use
Definition:
A 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.
FDA Product Codes
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
Premarket Submissions
Submission Number:
K250590
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
French
Item #1 - Size - @attributes - Value:
8
Item #1 - Size Type:
Catheter Gauge
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
130
Item #2 - Size Type:
Length