
Aga Medical Corp.
Free shipping on orders over $99 · 30-day returns
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 is an FDA 510(k)-cleared medical device (K083214) manufactured by Aga Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2009. Regulation: 8.