FDA.reportPublic FDA data

InterV

Primary DI
15060270906268
Brand
InterV
Company
PAN MEDICAL US CORPORATION
Model
INTV-15
Catalog number
INTV-15
Device description
8 Gauge 15mm Balloon Kyphoplasty Catheter
Published
2019-05-14
Public version status
New
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
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132620000INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPLPan Medical , Ltd.2014-04-16NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060270906268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506027090626815060270906268

GMDN Terms#

Term, Definition table
TermDefinition
Kyphoplasty balloon catheterA sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(727) 914-3932PanMed@PanMed.US

Regulatory Flags#

DUNS number
080228535
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
15056033810538OsteoflexINTV-CEM2016-11-04
15056033811252InterV Flex CatheterINTVMN-15-FLINTVMN-15-FL2019-06-05
15060270904295InterV Flex CatheterINTVMN-20-FLINTVMN-20-FL2019-06-05
15060270907937InterV-Curve PlusINTVMC-15-LINTVMC-15-L2019-06-05
15060270907944InterV-Curve PlusINTVMC-20-LINTVMC-20-L2019-06-05
15060270904257InterVINTVMC-10INTVMC-102019-05-15
15060270904264InterVINTVMC-15INTVMC-152019-05-15
15060270904271InterVINTVMC-20INTVMC-202019-05-15
15060270907913InterV-Curve PlusINTVMC-10-LINTVMC-10-L2019-05-15
15060270908880InterVINTVMN-10INTVMN-102019-05-15
15060270908897InterVINTVMN-15INTVMN-152019-05-15
15060270908903InterVINTVMN-20INTVMN-202019-05-15
15060270905155InterVINTVM-10INTVM-102019-05-14
15060270905179InterVINTVM-15INTVM-152019-05-14
15060270905186InterVINTVM-20INTVM-202019-05-14
15060270906251InterVINTV-10INTV-102019-05-14
15060270906275InterVINTV-20INTV-202019-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056336SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056343SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-31
08800038056145SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056176SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056183SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-19
08800038055643SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2023-08-30
08800104089473Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
08800104089480Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
07613327554663OmnicurveSTRYKER CORPORATIONHRX2022-04-12