510(k) Premarket Notification

• Device Classification Name: introducer, catheter
• 510(K) Number: K122980
• Model: RM*ES6J10HQD, RM*ES6F16HQ, RM*RS6J10PQ, RM*RS6C10PQ
• Device Name: GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
• Applicant: TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton, MD 21921
• Contact: daniel r plonski
• Regulation Number: 870.1340
• Classification Product Code: DYB
• Date Received: 09/26/2012
• Decision Date: 12/11/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No