FDA.reportPublic FDA data

HeartLight

Primary DI
00868976000109
Brand
HeartLight
Company
CARDIOFOCUS, INC.
Model
18-2531-N250
Catalog number
18-2531-N250
Device description
Laser Ablation Balloon Catheter
Published
2016-06-15
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150026000HEARTLIGHT ENDOSCOPIC ABLATION SYSTEMCardiofocus, Inc.2016-04-01OAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868976000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868976000109008689760001098689760001090868976000109

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ablation laser system beam guide-catheterA sterile, flexible, steerable catheter intended to be used as part of a cardiac ablation laser system to invasively direct and deliver laser energy to the endocardium of a beating heart for the ablation of specific areas in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length107Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(844)527-3723customerservice@cardiofocus.com

Regulatory Flags#

DUNS number
068966261
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859373007433HeartLight18-500018-50002020-05-19
00859373007440HeartLight18-495218-49522020-05-19
00859373007464HeartLight18-495718-49572020-05-19
00859373007495HeartLight18-503318-50332020-05-19
00868976000147HeartLight18-335618-33562016-06-15
00868976000116HeartLight18-295918-29592018-10-03
00868976000161HeartLight18-424718-42472018-10-03
00868976000178HeartLight18-4000-27A18-4000-27A2018-10-03
00868976000123HeartLight18-144718-14472016-06-15
00868976000130HeartLight18-134218-13422016-06-15
00868976000154HeartLightCF980-E10-US18-30552016-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
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05415067052056TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052063TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052216TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052223TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAE2025-08-30
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00763000995003N/AMEDTRONIC, INC.OAE2025-04-12
20763000954363N/AMEDTRONIC, INC.OAE2025-02-22
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAE2025-01-13
00763000708917DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.OAE2024-12-14