FDA.reportPublic FDA data

Therapy™

Primary DI
05414734308564
Brand
Therapy™
Company
IRVINE BIOMEDICAL, INC.
Model
IBI-84308
Catalog number
IBI-84308
Device description
Ablation Catheter
Published
2014-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060019000IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFIrvine Biomedical, Inc.2007-03-16OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734308564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734308564054147343085645414734308564

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping/radio-frequency ablation catheter, single-useA sterile, flexible, steerable catheter intended to be used as part of a cardiac mapping system and/or a radio-frequency cardiac ablation system to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping, and/or to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart, in the evaluation/treatment of cardiac arrhythmias. 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 Gauge7French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep cool, dry and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
926346966
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734303415Inquiry™IBI-81199IBI-811992016-03-18
05414734303538Inquiry™IBI-81213IBI-812132015-02-10
05414734303613Inquiry™IBI-81221IBI-812212015-02-10
05414734309257NAIBI-85942IBI-859422025-12-09
05415067053190ViewFlex™ICE-VF-SE-2D-01ICE-VF-SE-2D-012025-11-21
05415067002082ViewFlex™D087031D0870312016-01-12
05415067016669Cool Point™H701666H7016662024-01-12
05414734308830NAIBI-85710IBI-857102014-10-31
05414734309080NAIBI-85786IBI-857862014-10-31
05415067008985Cool Point™IBI-89003IBI-890032014-09-29
05414734258616Cool Point™85785857852014-09-29
05414734302975Inquiry™IBI-81104IBI-811042015-02-10
05414734303132Inquiry™IBI-81120IBI-811202015-03-10
05414734303149Inquiry™IBI-81121IBI-811212015-03-10
05414734303163Inquiry™IBI-81124IBI-811242015-03-10
05414734303170Inquiry™IBI-81125IBI-811252015-05-22
05414734303187Inquiry™IBI-81126IBI-811262015-05-22
05414734303217Inquiry™IBI-81130IBI-811302015-03-10
05414734303248Inquiry™IBI-81134IBI-811342015-03-10
05414734303309Inquiry™IBI-81144IBI-811442015-03-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
20763000995007N/AMEDTRONIC, INC.OAD2025-04-12
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAD2025-01-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAD2024-12-06
00763000871772NAMEDTRONIC, INC.OAD2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAD2024-11-04
20763000871776NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2024-11-04
00191506020798RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
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04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHOAD2024-09-01
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