
Plan 1 Health, S.R.L.
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PAINFUSOR CATHETER is an FDA 510(k)-cleared medical device (K111031) manufactured by Plan 1 Health, S.R.L.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2011. Regulation: 8.