INTRODUCER, CAT. #INT-07FR.

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS CATHETER INTRODUCER ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexSeal Introducer Sheath with Hydrophilic Coating

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019

FDA 510(k)

FDA Class 2 ·Cardiovascular

Element Vascular Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE MEDICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

TLAB® Transvenous Liver Biopsy System (TF-18C)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO MEDAMICUS AXIA RSN

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPREADABLE SHEATH INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPi-Ease Epicardial Access Device (EAS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHETER INTRODUCERS, ARTERISE

FDA 510(k)

FDA Class 2 ·Cardiovascular