FDA.reportPublic FDA data

Ablacon™ Mapping Catheter

Primary DI
00860457001551
Brand
Ablacon™ Mapping Catheter
Company
Ablacon Inc.
Model
AB-0003-60
Device description
The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These signals may be used for analysis with mapping systems. The Ablacath™ Mapping Catheter may also be used to deliver externally generated pacing stimuli.
Published
2023-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTDCatheter, Intracardiac Mapping, High-Density Array

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTDCatheter, Intracardiac Mapping, High-Density ArrayCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223666000Ablacath™ Mapping CatheterAblacon, Inc.2023-03-17MTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860457001551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860457001551008604570015518604570015510860457001551

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13039555620contact@ablacon.com

Regulatory Flags#

DUNS number
106083214
Device count
1
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860457001520Ablacath System Interconnect CableAB-00052025-02-21
00860457001568Ablamap® SystemAB-00072023-12-07
00860457001513Ablacath Catheter Extension CableAB-00042025-02-21
00860457001544Ablacon™ Mapping CatheterAB-0003-502023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064686166OptiMap Catheter - 60mmCortex, Inc.MTD2026-05-15
00850064686159OptiMap Catheter - 50mmCortex, Inc.MTD2026-04-02
00850064686067OptiMap™ Catheter - 50mmCortex, Inc.MTD2025-07-24
00850064686074OptiMap™ Catheter - 60mmCortex, Inc.MTD2025-07-10
05415067049889Advisor™ HD Grid X, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2024-08-23
00841824105560ECOIIW.H.P.M. INC.MTD2024-08-22
00860457001544Ablacon™ Mapping CatheterAblacon Inc.MTD2023-12-07
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835021110OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021127OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021134OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021141OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021158OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021233OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10888551045179NASTERILMED, INC.MTD2021-10-12
10888551045186NASTERILMED, INC.MTD2021-10-12
10888551045193NASTERILMED, INC.MTD2021-10-12
10888551045209NASTERILMED, INC.MTD2021-10-12
00857042007401AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
00857042007418AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
10846835022056CARTO 3 System eco Interface CableBiosense Webster IncMTD2021-07-30
05415067028198Advisor™ HD Grid, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2018-05-01
00857042007029AcQMapACUTUS MEDICAL, INC.MTD2018-02-15
08714729780434Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780441Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780458Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780465Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780472Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
10846835009576PENTARAY NAVBiosense Webster IncMTD2016-09-16