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# FDA Approves Cardiovascular Systems Replacement Saline Pump
- URL: https://www.fdaweb.com/fda-approves-cardiovascular-systems-replacement-saline-pump/
- Published: 2017-05-04T12:00:00.000Z
- Updated: 2026-09-14T22:21:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138615

FDA has approved a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems. The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company recalled last month. The company anticipates replacing all recalled units by no later than 8/31.

  
The device treats calcified and fibrotic plaque in arterial vessels throughout the leg. To date, over 308,000 units have been sold to treatment centers across the U.S., according to Cardiovascular Systems.