FDA.reportPublic FDA data

EasyFinder Fixed Curve Diagnostic Catheter

Primary DI
06952450942604
Brand
EasyFinder Fixed Curve Diagnostic Catheter
Company
Shanghai Microport Ep Medtech Co., Ltd.
Model
EPD6FD010
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K210313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210313000EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterShanghai Microport EP Medtech Co., Ltd.2022-12-30DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952450942604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952450942604069524509426046952450942604

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.

Regulatory Flags#

DUNS number
542965535
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06952450910016 PathBuilder Transseptal NeedleTNS56192024-02-22
06952450910023 PathBuilder Transseptal NeedleTNM56192024-02-22
06952450910030 PathBuilder Transseptal NeedleTNM71182024-02-22
06952450910047 PathBuilder Transseptal NeedleTNM89182024-02-22
06952450910054 PathBuilder Transseptal NeedleTNM98182024-02-22
06952450910061PathBuilder Transseptal NeedleTNL71182024-02-22
06952450910078PathBuilder Transseptal NeedleTNL98182024-02-22
06952450910085 PathBuilder Transseptal NeedleTNL89182024-02-22
06952450948101PathBuilder Transseptal Guiding IntroducerTSL163 8 2024-02-26
06952450948118PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948125PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948132PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948149PathBuilder Transseptal Guiding IntroducerTSL16385 2024-02-26
06952450956878PathBuilder Transseptal Guiding IntroducerTSL0818 2024-02-26
06952450956885PathBuilder Transseptal Guiding IntroducerTSL1818 2024-02-26
06952450956892PathBuilder Transseptal Guiding IntroducerTSL08185 2024-02-26
06952450956908PathBuilder Transseptal Guiding IntroducerTSL18185 2024-02-26
06952450956915PathBuilder Transseptal Guiding IntroducerTSR0638 2024-02-26
06952450956922PathBuilder Transseptal Guiding IntroducerTSR1638 2024-02-26
06952450956939PathBuilder Transseptal Guiding IntroducerTSR06385 2024-02-26

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Primary DI, Brand, Company table
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00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
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04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
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20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25
00643169778184NAMEDTRONIC, INC.DRF2016-11-04
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