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# FDA Clears OrbusNeich Coronary Balloon
- URL: https://www.fdaweb.com/fda-clears-orbusneich-coronary-balloon/
- Published: 2018-03-02T12:00:00.000Z
- Updated: 2026-09-14T23:27:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140886

FDA has given 510(k) clearance to the Cardiovascular Systems’ OrbusNeich 1.0mm Sapphire II Pro coronary balloon. The company says it is the first and only 1.0mm coronary balloon available in the U.S.