FDA.reportPublic FDA data

TactiCath™

Primary DI
05415067027641
Brand
TactiCath™
Company
ST. JUDE MEDICAL, INC.
Model
Sensor Enabled™
Catalog number
A-TCSE-DF
Device description
Contact Force Ablation Catheter
Published
2019-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067027641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067027641054150670276415415067027641

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length115Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Store in a cool, dark place.
Storage Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

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Primary DI, Brand, Company table
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05415067046734Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
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00763000709051DiamondTemp™ Irrigation PumpMEDTRONIC, INC.OAE2024-12-13
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00763000709150DiamondTemp™ Genconnect CableMEDTRONIC, INC.OAE2024-01-12
00763000536671DiamondTemp™ Bidirectional Ablation CatheterMEDTRONIC, INC.OAE2023-12-30
00763000536688DiamondTemp™ Bidirectional Ablation CatheterMEDTRONIC, INC.OAE2023-12-30
00763000709198DiamondTemp™ Foot SwitchMEDTRONIC, INC.OAE2023-12-16
00763000709181DiamondTemp™ Irrigation Tubing SetMEDTRONIC, INC.OAE2023-11-26
00763000709174DiamondTemp™ Irrigation Tubing SetMEDTRONIC, INC.OAE2023-11-26
00840216123014ASP MEDICALAsp Global, LLCOAE2023-10-19
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08714729992714SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-25
08714729992721SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-25
08714729997481SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-25
00191506007737SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
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00191506016463POLARx™ FITBOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
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