MEDTRONIC 3F THERAPEUTICS, INC.

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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

HOLDER, HEART-VALVE, PROSTHESIS (DTJ) (5) SIZER, HEART-VALVE, PROSTHESIS (DTI) (5)

Premarket Exempt

No Yes

Clear

Freestyle™ - 00763000318338 Catalog Number :

Device Description : OBTURATORS 7990SET FREESTYLE 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

NA - 00763000318345 Catalog Number :

Device Description : HANDLE 7639 VALVE 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

NA - 00763000318352 Catalog Number :

Device Description : HANDLE 7639XL VALVE XL 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

NA - 00763000318369 Catalog Number :

Device Description : ACCESSORY 7642 LOCK NUT 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

MOSAIC™ - 00763000318390 Catalog Number :

Device Description : OBTURATORS 7310 MOSAIC MITRAL 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Hancock™ II - 00763000318413 Catalog Number :

Device Description : OBTURATOR 7505SET HK II AORTIC 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Hancock™ II - 00763000318420 Catalog Number :

Device Description : OBTURATOR 7510SET HK II MITRAL 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

NA - 00763000318437 Catalog Number :

Device Description : HANDLE 7615 ANNULOPLASTY 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

NA - 00763000318444 Catalog Number :

Device Description : HANDLE 7615XL ANNULOPLASTY XL 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

NA - 00763000318468 Catalog Number :

Device Description : HANDLE 7686 ANNULOPLASTY 29L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

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