FDA.report

MAGiC Magnetic Interventional Ablation Catheter

Primary DI
04044508152218
Brand
MAGiC Magnetic Interventional Ablation Catheter
Company
OSYPKA GmbH
Model
8C-21-031Z-B
Catalog number
001-009740-2
Device description
The MAGiC catheter is a robotically navigated magnetic interventional ablation catheter for minimally invasive cardiac ablation procedures. Used in conjunction with Stereotaxis robotic systems, the MAGIC catheter is designed to provide unparalleled catheter precision, reach, and stability when diagnosing and treating cardiac arrhythmias.
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LPBCardiac Ablation Percutaneous Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions

SubmissionSupplement
P240014000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P240014000MAGiC Ablation CatheterStereotaxis, Inc.2026-01-05LPB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04044508152218PackageGS11In Commercial Distribution
04044508152225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04044508152218040445081522184044508152218
04044508152225040445081522254044508152225

GMDN Terms

TermDefinition
Cardiac radio-frequency ablation system catheterA sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter2.8Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure60 KiloPascal102 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
316276799
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandModelCatalogPublished
04044508136959MAGIC - iCONNECT82062001-009074-12026-03-13
04044508137031iCONNECT - AMPERE82066001-009079-12026-03-13

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