
Boston Scientific Corporation
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Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 is an FDA 510(k)-cleared medical device (K241683) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2024. Regulation: 8.

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