FDA.reportPublic FDA data

HyperGlide

Primary DI
00763000294502
Brand
HyperGlide
Company
Micro Therapeutics, Inc.
Model
104-4315
Device description
BALLOON SYSTEM 104-4315 V20 HYPERGLIDE
Published
2020-08-01
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
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
00763000294502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000294502007630002945027630002945020763000294502

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA 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 malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C).
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000270179Solitaire™ X-PACKXPACK2012019-11-08
00763000270193Solitaire™ X-PACKXPACK2032019-11-08
00763000270353Solitaire™ X-PACKXPACK3012019-11-08
00763000270377Solitaire™ X-PACKXPACK3032019-11-08
00763000270537Solitaire™ X-PACKXPACK3192019-11-08
00763000270551Solitaire™ X-PACKXPACK3212019-11-08
00763000270216Solitaire™ X-PACKXPACK2052019-11-07
00763000270230Solitaire™ X-PACKXPACK2072019-11-07
00763000270254Solitaire™ X-PACKXPACK2092019-11-07
00763000270292Solitaire™ X-PACKXPACK2132019-11-07
00763000270315Solitaire™ X-PACKXPACK2152019-11-07
00763000270339Solitaire™ X-PACKXPACK2172019-11-07
00763000270391Solitaire™ X-PACKXPACK3052019-11-07
00763000270414Solitaire™ X-PACKXPACK3072019-11-07
00763000270438Solitaire™ X-PACKXPACK3092019-11-07
00763000270476Solitaire™ X-PACKXPACK3132019-11-07
00763000270490Solitaire™ X-PACKXPACK3152019-11-07
00763000270513Solitaire™ X-PACKXPACK3172019-11-07
00763000270582Solitaire™ X-PACKXPACK3242019-11-07
00763000270605Solitaire™ X-PACKXPACK3262019-11-07

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