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

SIZER, HEART-VALVE, PROSTHESIS (DTI) (8) HOLDER, HEART-VALVE, PROSTHESIS (DTJ) (1) INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (1)

Premarket Exempt

No Yes

Clear

NA - 00763000318475 Catalog Number :

Device Description : HANDLE 7686XL ANNULOPLASTY 29L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

Contour 3D™ - 00763000318482 Catalog Number :

Device Description : SIZER SET 7690S CONTOUR 3D 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Duran AnCore™ - 00763000318499 Catalog Number :

Device Description : SIZER SET 7620S DURAN ANCORE 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Simulus™ - 00763000318512 Catalog Number :

Device Description : SIZER SET 750 SIMULUS FLEXIBLE 1L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Simulus™ - 00763000318529 Catalog Number :

Device Description : SIZER SET 755 SIMULUS FLEXIBLEROBOTIC CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Simulus™ - 00763000318536 Catalog Number :

Device Description : HANDLE 752 SIMULUS ANNULOPLASTY CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Simulus™ - 00763000318543 Catalog Number :

Device Description : SIZER SET 850 SEMI-RIDGID SIMULUS CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Medtronic Open Pivot™ - 00763000318550 Catalog Number :

Device Description : SIZER SET 576 OPHV NITINOL 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

Medtronic Open Pivot™ - 00763000318581 Catalog Number :

Device Description : HANDLE BENDABLE 569 OPHV 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : No

Device Count : 1

Medtronic Open Pivot™ - 00763000318598 Catalog Number :

Device Description : SIZER SET 577 OPHV STANDARD 26L CE

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTI

Prescription Use : No

Device Count : 1

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