FDA.reportPublic FDA data

FLASH Ostial System

Primary DI
M917OAB7019BA0
Brand
FLASH Ostial System
Company
Verge Medical, Inc.
Model
OAB7019BA
Catalog number
OAB7019BA
Device description
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm
Published
2016-09-22
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
DQYCatheter, Percutaneous
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122379000FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMOstial Corporation2012-09-05LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M917OAB7019BA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location at room temperature (~23°C)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-352-7411info@ostialcorp.com
1-844-352-7411customerservice@vergemedical.com

Regulatory Flags#

DUNS number
078708447
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemFF30AFF30A2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemFF35AFF35A2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemFF40AFF40A2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemFF45AFF45A2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemFF50AFF50A2026-05-22
M917RVHD0RoVo Mechanical Thrombectomy SystemRVHDRVHD2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemRVHDRVHD2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVRG7513B3VRG7513B32026-02-06
M917OTW7017BA0FLASH Ostial System OTWOTW7017BAOTW7017BA2016-09-22
M917OAB6019BA0FLASH Ostial SystemOAB6019BAOAB6019BA2016-09-22
M917OCB4014BA0FLASH Ostial SystemOCB4014BAOCB4014BA2016-09-22
M917OCB4514BA0FLASH Ostial SystemOCB4514BAOCB4514BA2016-09-22
M917OCB5019BA0FLASH Ostial SystemOCB5019BAOCB5019BA2016-09-22
M917OAB6014BA0FLASH Ostial SystemOAB6014BAOAB6014BA2016-09-22
M917OTW6012BA0FLASH Ostial System OTWOTW6012BAOTW6012BA2016-09-22
M917OTW7012BA0FLASH Ostial System OTWOTW7012BAOTW7012BA2016-09-22
M917OCB3008BA0FLASH MINI Ostial SystemOCB3008BAOCB3008BA2016-09-22
M917OCB3508BA0FLASH MINI Ostial SystemOCB3508BAOCB3508BA2016-09-22
M917OCB4008BA0FLASH MINI Ostial SystemOCB4008BAOCB4008BA2016-09-22
M917OCB4508BA0FLASH MINI Ostial SystemOCB4508BAOCB4508BA2016-09-22

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Primary DI, Brand, Company table
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07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
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