FLASH Ostial System

FDA UDI

Class II (US FDA UDI)

by Verge Medical, Inc.

Identity

Trade Name: FLASH Ostial System FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm FDA UDI
Model / Reference: OCB4514BA FDA UDI
Description: FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm FDA UDI

Identifiers

Catalog Number: OCB4514BA FDA UDI
Primary DI / UDI-DI: M917OCB4514BA0 FDA UDI
510(k) Number: K113775 FDA UDI
K120738 FDA UDI
K122178 FDA UDI
K122379 FDA UDI
FDA Product Code: LOX FDA UDI
DQY FDA UDI
LIT FDA UDI
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

FLASH Ostial System by Verge Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K113775 also covers:

K120738 also covers:

K122178 also covers:

K122379 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Verge Medical, Inc.

Sources (1)

FDA UDI 8f9f3214-981c-414f-8268-f2c96ec2a6d0 38 fields · synced Jun 8, 2026