ST. JUDE MEDICAL, INC.

Address:387 TECHNOLOGY CIRCLE, NW,ATL,GA,30313,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

INTRODUCER, CATHETER (DYB) (4) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (1)

Premarket Exempt

No Yes

Clear

EnSite Precision™ - 15415067025934 Catalog Number : EN0020-P

Device Description : Surface Electrode Kit

Device Class : 2

Duns Number: 149818952

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 5

Portico Solo™ - 15415067028157 Catalog Number : PRTSOLO-19

Device Description : Re-Collapsible IntroducerHydrophillic Coated11F Comparable Sheath ID19F Expanded Profile

Device Class : 2

Duns Number: 149818952

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Portico Solo™ - 15415067028164 Catalog Number : PRTSOLO-20

Device Description : Re-Collapsible IntroducerHydrophillic Coated12F Comparable Sheath ID20F Expanded Profile

Device Class : 2

Duns Number: 149818952

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Portico Solo™ - 25415067028154 Catalog Number : PRTSOLO-19

Device Description : Re-Collapsible IntroducerHydrophillic Coated11F Comparable Sheath ID19F Expanded Profile

Device Class : 2

Duns Number: 149818952

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Portico Solo™ - 25415067028161 Catalog Number : PRTSOLO-20

Device Description : Re-Collapsible IntroducerHydrophillic Coated12F Comparable Sheath ID20F Expanded Profile

Device Class : 2

Duns Number: 149818952

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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