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

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 is an FDA 510(k)-cleared medical device (K012489) manufactured by Appriva Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2001. Regulation: 8.