FDA.reportPublic FDA data

FLASH Ostial System

Primary DI
M917OCB4514BA0
Brand
FLASH Ostial System
Company
Verge Medical, Inc.
Model
OCB4514BA
Catalog number
OCB4514BA
Device description
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
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
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113775000
K120738000
K122178000
K122379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113775000FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMOstial Corporation2012-06-29LOX
K120738000FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMOstial Corporation2012-03-29LIT
K122178000FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1Ostial Corporation2012-10-11LOX
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
M917OCB4514BA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. 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
M917OAB7019BA0FLASH Ostial SystemOAB7019BAOAB7019BA2016-09-22
M917OCB4014BA0FLASH Ostial SystemOCB4014BAOCB4014BA2016-09-22
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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