Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Pre-Formed Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREDICATE III GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYDROPHILIC COATED GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTFE Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pre-Formed Extra Support Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

MANDREL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MANDREL GUIDEWIRES OR M-WIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HI TORQUE CONNECT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MANDREL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTAVI HYDROPHILIC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENROUTE 0.014 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANCHORWIRE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pre-Formed Blue

FDA 510(k)

FDA Class 2 ·Cardiovascular

Predicate III Guidewire

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II, Blazer II HTD, Blazer Prime HTD

PRE-FORMED GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular