510(k) Premarket Notification

• Device Classification Name: anesthesia conduction kit
• 510(K) Number: K121403
• Device Name: CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
• Applicant: TELEFLEX, INC.; 2400 bernville road; reading, PA 19605
• Contact: paul amudala
• Regulation Number: 868.5140
• Classification Product Code: CAZ
• Date Received: 05/21/2012
• Decision Date: 06/20/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Anesthesiology
• Review Advisory Committee: Anesthesiology
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No