
Boston Scientific Scimed, Inc.
Free shipping on orders over $99 · 30-day returns
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K021735) manufactured by Boston Scientific Scimed, 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 7, 2002. Regulation: 8.