OSTIAL CORPORATION

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheters, Transluminal Coronary Angioplasty, Percutaneous (LOX) (7) Catheter, Angioplasty, Peripheral, Transluminal (LIT) (6) Catheter, Percutaneous (DQY) (6)

Premarket Exempt

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FLASH Ostial System - M917OAB6014BA0 Catalog Number : OAB6014BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 12mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

FLASH Ostial System - M917OAB6019BA0 Catalog Number : OAB6019BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 17mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

FLASH Ostial System - M917OAB7019BA0 Catalog Number : OAB7019BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

FLASH MINI Ostial System - M917OCB3008BA0 Catalog Number : OCB3008BA

Device Description : FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 3.0mm x 8mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

FLASH MINI Ostial System - M917OCB3508BA0 Catalog Number : OCB3508BA

Device Description : FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 3.5mm x 8mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

FLASH MINI Ostial System - M917OCB4008BA0 Catalog Number : OCB4008BA

Device Description : FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 8mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

FLASH Ostial System - M917OCB4014BA0 Catalog Number : OCB4014BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LIT, DQY, LOX

Prescription Use : Yes

Device Count : 1

FLASH MINI Ostial System - M917OCB4508BA0 Catalog Number : OCB4508BA

Device Description : FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 8mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

FLASH Ostial System - M917OCB4514BA0 Catalog Number : OCB4514BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX, DQY, LIT

Prescription Use : Yes

Device Count : 1

FLASH Ostial System - M917OCB5014BA0 Catalog Number : OCB5014BA

Device Description : FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm

Device Class : 2

Duns Number: 078708447

Premarket Exempt : No

Product Code : LOX, DQY, LIT

Prescription Use : Yes

Device Count : 1

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