FDA.reportPublic FDA data

HyperFormTM

Primary DI
00847536005358
Brand
HyperFormTM
Company
Micro Therapeutics, Inc.
Model
104-4370
Device description
104-4370 HYPERFORM 3X7MM BALLOON SYS
Published
2016-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJNCatheter, intravascular occluding, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091458000
K101570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091458000HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104Ev3 Neurovascular2009-10-15MJN
K101570000HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMSMicro Therapeutics Dba Ev3 Neurovascular2010-07-13MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536005358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536005358008475360053588475360053580847536005358

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
826110710
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536036338PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-102023-12-31
00847536036390PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-252023-12-31
00847536036499PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-350-102023-12-31
00763000495626Axium™ Prime Detachable Coil SystemFC-9-20-3D2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemFC-9-30-3D2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemFC-10-30-3D2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemFC-10-40-3D2023-08-07
00763000488000Axium™ Detachable Coil SystemQC-2.5-2-HELIX2022-10-28
00763000488024Axium™ Detachable Coil SystemQC-2.5-6-HELIX2022-10-28
00763000488031Axium™ Detachable Coil SystemQC-2.5-8-HELIX2022-10-28
00763000488147Axium™ Detachable Coil SystemQC-7-30-HELIX2022-10-28
00763000488154Axium™ Detachable Coil SystemQC-8-20-HELIX2022-10-28
00763000488178Axium™ Detachable Coil SystemQC-9-20-HELIX2022-10-28
00763000488208Axium™ Detachable Coil SystemQC-10-30-HELIX2022-10-28
00763000488215Axium™ Detachable Coil SystemQC-12-30-HELIX2022-10-28
00763000488222Axium™ Detachable Coil SystemQC-12-40-HELIX2022-10-28
00763000488246Axium™ Detachable Coil SystemQC-14-40-HELIX2022-10-28
00763000488253Axium™ Detachable Coil SystemQC-16-30-HELIX2022-10-28
00763000488277Axium™ Detachable Coil SystemQC-18-40-HELIX2022-10-28
00763000488284Axium™ Detachable Coil SystemQC-20-40-HELIX2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060550816Bridge Plus occlusion balloonPhilips Image Guided Therapy CorporationMJN2025-10-09
00850001105118Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2025-06-20
00842429117545SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117552SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106907Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0590LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03