East End Medical I LLC

Address:10320 USA Today Way,Miramar,FL,33025,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) (3)

Premarket Exempt

Clear

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System - 08600035053013 Catalog Number : 3001

Device Description : SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System.Small size.

Device Class : 2

Duns Number: 118148023

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System - 08600035053020 Catalog Number : 3002

Device Description : SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System, Medium.

Device Class : 2

Duns Number: 118148023

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System - 08600035053037 Catalog Number : 3003

Device Description : SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Large size.

Device Class : 2

Duns Number: 118148023

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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