Rapid Obstructive Hydrocephalus, Rapid OH

Rapid Obstructive Hydrocephalus, Rapid OH is an FDA 510(k)-cleared medical device (K251533) manufactured by Ischemaview, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2025. Regulation: 8.