
Spectra Medical Devices, Inc.
Free shipping on orders over $99 · 30-day returns
SPECTRA GUIDEWIRE INTRODUCER NEEDLE is an FDA 510(k)-cleared medical device (K082580) manufactured by Spectra Medical Devices, 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 December 7, 2008. Regulation: 8.