CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

FDA 510(k)

FDA Class 2 ·Hematology

CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CareLink SmartSync Device Manager - Pacing System Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioInsight Cardiac Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cosine-10TM Diagnostic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface

FDA 510(k)

FDA Class 2 ·Cardiovascular