Argyle Peritoneal Dialysis Catheter And Kits, Argyle Presternal Peritoneal Dialysis Catheter And Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Catheter, Peritoneal, Long-term Indwelling

Covidien, Llc

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Argyle Peritoneal Dialysis Catheter And Kits, Argyle Presternal Peritoneal Dialysis Catheter And Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender.

Pre-market Notification Details

• Device ID: K180485
• 510k Number: K180485
• Device Name: Argyle Peritoneal Dialysis Catheter And Kits, Argyle Presternal Peritoneal Dialysis Catheter And Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
• Classification: Catheter, Peritoneal, Long-term Indwelling
• Applicant: Covidien, Llc 15 Hampshire Street Mansfield, MA 02048
• Contact: Carol Ming
• Correspondent: Carol Ming; Covidien, Llc 15 Hampshire Street Mansfield, MA 02048
• Product Code: FJS
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-23
• Decision Date: 2018-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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