Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter And Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter

Catheter, Intravascular, Diagnostic

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Beacon Tip Torcon Nb Advantage Catheter, Slip-cath Beacon Tip Catheter And Shuttle Select Slip-cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter.

Pre-market Notification Details

• Device ID: K173289
• 510k Number: K173289
• Device Name: Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter And Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
• Classification: Catheter, Intravascular, Diagnostic
• Applicant: Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Contact: David E. Chadwick
• Correspondent: David E. Chadwick; Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Product Code: DQO
• CFR Regulation Number: 870.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-16
• Decision Date: 2017-11-15
• Summary: summary

NIH GUDID Devices

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