
Bard Peripheral Vascular, Inc.
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UltraCor Twirl Breast Tissue Marker is an FDA 510(k)-cleared medical device (K243642) manufactured by Bard Peripheral Vascular, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2025. Regulation: 8.