FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

FAST-CATH TRANSSEPTAL CATHETER INTRODUCER is an FDA 510(k)-cleared medical device (K964518) manufactured by Daig 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 13, 1997. Regulation: 8.