510(k) Premarket Notification

• Device Classification Name: introducer, catheter
• 510(K) Number: K122854
• Models: I-01031-001A(3 FR.), I-01071-001A (7 FR.), I-01041-001A (4 FR.). I-01051-001A (5 FR.), I-01061-001A (6 FR. )
• Device Name: ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
• Applicant: ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.); 2400 bernville rd.; reading, PA 19605
• Contact: julie lawson
• Regulation Number: 870.1340
• Classification Product Code: DYB
• Date Received: 09/18/2012
• Decision Date: 01/04/2013
• 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