FDA.reportPublic FDA data

CardioGenesis

Primary DI
00877234000119
Brand
CardioGenesis
Company
Artivion, Inc.
Model
HP-PRL5
Catalog number
HP-PRL5
Device description
Pearl 5.0 Handpiece Delivery System
Published
2016-12-12
Public version status
Update
Distribution status
Not 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
MNOSystem, Laser, Transmyocardial Revascularization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNOSystem, Laser, Transmyocardial RevascularizationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970029011
P970029013
P970029015
P970029017
P970029018
P970029019
P970029020
P970029024
P970029026
P970029029

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970029011TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029013TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029015TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029017TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029018TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029019TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029020TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029024TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029026TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029029TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234000119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234000119008772340001198772340001190877234000119

GMDN Terms#

Term, Definition table
TermDefinition
Transmyocardial revascularization laser system beam guideA sterile, flexible, probe-like device intended to be connected to a cardiac laser system for the delivery of laser energy directly onto the heart during transmyocardial revascularization surgery (open surgical approach). It includes fibreoptic materials whereby a distal laser fibre of a specific width is intended to penetrate myocardium to create channels for the promotion of angiogenesis; it may include distal needles/tubing to allow injection of agents into the myocardium. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00clean, dry environment under conditions that protect against extremes in temperature and humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-419-3355xxx@xx.xx

Regulatory Flags#

DUNS number
119253177
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumPFP1X14PFP1X142026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumPFP8X14PFP8X142026-05-29
00877234000096CardioGenesisNS2000LSR-SG2100S2016-12-12
00877234000447CryoValve® SG Pulmonary Human Heart Valve SGPV00SGPV002015-09-11
00877234000454CryoValve® SG Pulmonary Human Heart Valve SGPV10SGPV102015-09-11
00877234000102CardioGenesisHP-SG3HP-SG32016-12-12
00877234001192"AMDS Hybrid Prosthesis (""AMDS"")"K039420AMDS40 2025-02-05
00877234001208"AMDS Hybrid Prosthesis (""AMDS"")"K039421AMDS4030 2025-02-05
00877234001215"AMDS Hybrid Prosthesis (""AMDS"")"K039422AMDS55 2025-02-05
00877234001222"AMDS Hybrid Prosthesis (""AMDS"")"K039423AMDS55402025-02-05
00877234001321"AMDS Hybrid Prosthesis (""AMDS"")"K038896AMDS4030c 2025-02-05
00877234001338"AMDS Hybrid Prosthesis (""AMDS"")"K038895AMDS40c 2025-02-05
10877234001298BioGlue Surgical AdhesiveBG3510-5-USBG3510-5-US2024-03-13
10877234001304BioGlue Surgical AdhesiveBG3515-5-USBG3515-5-US2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551425695n.a.Karl Storz GmbH & Co. KGMNO2024-12-20
00877234000096CardioGenesisArtivion, Inc.MNO2016-12-12
00877234000102CardioGenesisArtivion, Inc.MNO2016-12-12
00860701000101The Heart Laser Disposable TMR kitNovadaq Technologies IncMNO2014-09-17