Name: Scoreflex PTA Scoring Balloon Catheter
Brand: Orbusneich Medical Trading, Inc.
SKU: K182713

Scoreflex PTA Scoring Balloon Catheter is an FDA 510(k)-cleared medical device (K182713) manufactured by Orbusneich Medical Trading, 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 June 10, 2019. Regulation: 8.

Scoreflex PTA Scoring Balloon Catheter

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