FDA.reportPublic FDA data

HeartLight

Primary DI
00868976000130
Brand
HeartLight
Company
CARDIOFOCUS, INC.
Model
18-1342
Catalog number
18-1342
Device description
Balloon Fill Media
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
00868976000130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868976000130008689760001308689760001300868976000130

GMDN Terms#

Term, Definition table
TermDefinition
Vascular balloon catheter fill-mediaA dedicated sterile solution (e.g., deuterium oxide) intended to be pumped into an appropriate vascular balloon catheter (e.g., cardiac laser system beam guide-catheter with balloon tip) to inflate the distal balloon during a vascular procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume95Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No direct sunlight
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
068966261
Device count
1
Lot or batch
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
00868976000109HeartLight18-2531-N25018-2531-N2502016-06-15
00868976000123HeartLight18-144718-14472016-06-15
00868976000154HeartLightCF980-E10-US18-30552016-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
05415067051943N/AST. JUDE MEDICAL, INC.OAE2025-10-31
05415067051950TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067051998TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052018TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052025TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
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
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2025-08-30
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
00763000709051DiamondTemp™ Irrigation PumpMEDTRONIC, INC.OAE2024-12-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAE2024-12-06
00763000871772NAMEDTRONIC, INC.OAE2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAE2024-11-04
00763000871802NAMEDTRONIC, INC.OAE2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAE2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2024-11-04