SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP

SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP is an FDA 510(k)-cleared medical device (K935905) manufactured by Scimed Life Systems, 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 March 9, 1994. Regulation: 8.