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Arrow Intl., Inc.
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ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL is an FDA 510(k)-cleared medical device (K000729) manufactured by Arrow Intl., 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 May 18, 2000. Regulation: 8.