RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS is an FDA 510(k)-cleared medical device (K060288) manufactured by Spire Biomedical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2006. Regulation: 8.