Truvic Medical, Inc.

Address:1359 DELL AVE,Campbell,CA,95008,US

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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

Peripheral Mechanical Thrombectomy With Aspiration (QEW) (10)

Premarket Exempt

Clear

Prodigy Twist™ - 00850032079006 Catalog Number : TWIST5F

Device Description : 5F Prodigy Twist™, 177 cm

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy Twist™ - 00850032079013 Catalog Number : TWIST6F

Device Description : 6F Prodigy Twist™, 154 cm

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy Twist™ - 00850032079020 Catalog Number : TWIST8F

Device Description : 8F Prodigy Twist™, 107 cm

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy Twist™ - 00850032079037 Catalog Number : TWIST8F-S

Device Description : 8F Short Prodigy Twist™, 67 cm

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy™ Catheter - 00850032079044 Catalog Number : PRODIGY5F

Device Description : 5F Prodigy™ CatheterLength: 160 cmInner Diameter: 0.055 inOuter Diameter: 0.067 5F Prodigy™ CatheterLength: 160 cmInner Diameter: 0.055 inOuter Diameter: 0.067 in (1.70 mm)

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy™ Catheter - 00850032079051 Catalog Number : PRODIGY6F

Device Description : 6F Prodigy™ CatheterLength: 137 cmInner Diameter: 0.071 inOuter Diameter: 0.085 6F Prodigy™ CatheterLength: 137 cmInner Diameter: 0.071 inOuter Diameter: 0.085 in (2.13 mm)

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy™ Catheter - 00850032079068 Catalog Number : PRODIGY8F

Device Description : 8F Prodigy™ CatheterLength: 90 cmInner Diameter: 0.088 inOuter Diameter: 0.110 i 8F Prodigy™ CatheterLength: 90 cmInner Diameter: 0.088 inOuter Diameter: 0.110 in (2.80 mm)

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy™ Catheter - 00850032079075 Catalog Number : PRODIGY8F-S

Device Description : 8F Short Prodigy™ CatheterLength: 50 cmInner Diameter: 0.088 inOuter Diameter: 0 8F Short Prodigy™ CatheterLength: 50 cmInner Diameter: 0.088 inOuter Diameter: 0.110 in (2.80 mm)

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Hotshot™ Controller - 00850032079082 Catalog Number : HOTSHOT

Device Description : Prodigy Hotshot™ Controller

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Prodigy Twist™ - 08500320790008 Catalog Number : TWIST5F

Device Description : 5F Prodigy Twist™, 177 cm

Device Class : 2

Duns Number: 104006631

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

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