
Acumen Medical, Inc.
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ACUMEN SHEATH, MODEL TTW7807 is an FDA 510(k)-cleared medical device (K042376) manufactured by Acumen Medical, 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 October 25, 2004. Regulation: 8.