FDA.reportPublic FDA data

Cardioblate®

Primary DI
00613994299413
Brand
Cardioblate®
Company
MEDTRONIC, INC.
Model
6800001AM
Device description
GENERATOR 6800001AM CARDIOBLATE EN
Published
2016-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCLSurgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060400000CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLATMedtronic, Inc.2006-02-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994299413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994299413006139942994136139942994130613994299413

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system generatorA mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150027538Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00763000841607Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2025-05-18
10884521851566ValleylabCovidien LPOCL2025-05-12
10840143911767AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
30840143911761AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
10884521829527ValleylabCovidien LPOCL2024-10-03
10884521829534ValleylabCovidien LPOCL2024-10-03
00763000841591Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2024-04-28
10840143905995AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905834AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
30840143904817AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
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30840143904114AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905209AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
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10840143904134AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.OCL2021-08-12
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10840143904110AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
10840143904127AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
30840143903803Coagulation RF CableATRICURE, INC.OCL2021-05-24
10840143904554EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.OCL2021-05-24
10840143904561nContact RF GeneratorATRICURE, INC.OCL2021-05-24
30840143902134nContact RF GeneratorATRICURE, INC.OCL2021-05-24
10840143901454nContact RF GeneratorATRICURE, INC.OCL2021-01-11
10840143902161Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902222Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902253Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11