Prelude Wave Hydrophilic Sheath Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Transjugular Liver Access Sets

FDA 510(k)

FDA Class 2 ·Cardiovascular

Endophys Pressure Sensing Sheath Kit- 8F

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vado Steerable Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUCISE URETERAL CUTTING CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDAMICUS AXIA RSN

FDA 510(k)

FDA Class 2 ·Cardiovascular

APEEL CS CATHETER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaCross Connect Transseptal Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioCardia 8.5 F Avance Steerable lntroducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTFE PEEL AWAY MICROINTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DuraSheath Introducer Sheath System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE DRYSEAL SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexSeal Introducer Sheath with Hydrophilic Coating

FDA 510(k)

FDA Class 2 ·Cardiovascular

LONG LENGTH PERCUTANEOUS INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENGAGE/ENGAGE TR INTRODUCERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROSSOVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Performer Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular