ACCLARENT, INC.

Address:31 Technology Dr Suite 200,Irvine,CA,92618,US

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Filters

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

CANNULA, SINUS (KAM) (5) BRONCHOSCOPE ACCESSORY (KTI) (2) SOURCE, CARRIER, FIBEROPTIC LIGHT (EQH) (2) INSTRUMENT, ENT MANUAL SURGICAL (LRC) (1)

Premarket Exempt

No Yes

Clear

INSPIRA AIR - 10705031063297 Catalog Number : BC1040A

Device Description : INSPIRA AIR BALLOON DILATION SYSTEM 10x40

Device Class : 2

Duns Number: 361092450

Premarket Exempt : No

Product Code : KTI

Prescription Use : Yes

Device Count : 1

INSPIRA AIR - 10705031063310 Catalog Number : BC1440A

Device Description : INSPIRA AIR BALLOON DILATION SYSTEM 14x40

Device Class : 2

Duns Number: 361092450

Premarket Exempt : No

Product Code : KTI

Prescription Use : Yes

Device Count : 1

RELIEVA LUMA - 10705031063341 Catalog Number : SISLGCAACMI

Device Description : RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - ACMI / STRYKER

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : Yes

Device Count : 1

RELIEVA LUMA - 10705031063358 Catalog Number : SISLGCAWOLF

Device Description : RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - WOLF / DYONICS

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : Yes

Device Count : 1

RELIEVA FLEX - 10705031063372 Catalog Number : GC000RF

Device Description : RELIEVA FLEX SINUS GUIDE CATHETER S-0

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

RELIEVA FLEX - 10705031063426 Catalog Number : GC070CRF

Device Description : RELIEVA FLEX SINUS GUIDE CATHETER F-70C

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

RELIEVA FLEX - 10705031063457 Catalog Number : GC090RF

Device Description : RELIEVA FLEX SINUS GUIDE CATHETER M-90

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

RELIEVA FLEX - 10705031063488 Catalog Number : GC110RF

Device Description : RELIEVA FLEX SINUS GUIDE CATHETER M-110

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

RELIEVA SIDEKICK LP - 10705031063549 Catalog Number : SDKKLP

Device Description : RELIEVA SIDEKICK SINUS GUIDE HANDLE LOW PROFILE

Device Class : 1

Duns Number: 361092450

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

ACCLARENT BALLOON INFLATION DEVICE - 10705031063570 Catalog Number : BID30

Device Description : ACCLARENT INFLATION DEVICE

Device Class : 1

Duns Number: 361092450

Premarket Exempt : No

Product Code : LRC

Prescription Use : Yes

Device Count : 1

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