Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) is an FDA 510(k)-cleared medical device (K170922) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2017. Regulation: 8.