CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...

Catheter, Hemodialysis, Implanted

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Cannon Ii Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep(r) Retrograde Chronic....

Pre-market Notification Details

• Device ID: K111117
• 510k Number: K111117
• Device Name: CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
• Classification: Catheter, Hemodialysis, Implanted
• Applicant: Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading, PA 19605
• Contact: Suzanne Schorle
• Correspondent: Suzanne Schorle; Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading, PA 19605
• Product Code: MSD
• CFR Regulation Number: 876.5540 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-21
• Decision Date: 2011-06-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50801902039045	K111117	000
40801902096690	K111117	000
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