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
20884521055930	K180485	000
10884521004535	K180485	000
10884521004573	K180485	000
10884521004306	K180485	000
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20884521196091	K180485	000
10884521196087	K180485	000
10884521004115	K180485	000
10884521004139	K180485	000
10884521004528	K180485	000
20884521055657	K180485	000
10884521056039	K180485	000
10884521086845	K180485	000
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10884521004627	K180485	000
10884521004634	K180485	000
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10884521055490	K180485	000
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10884521004047	K180485	000
10884521004054	K180485	000
10884521004061	K180485	000
10884521004078	K180485	000
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10884521004191	K180485	000
20884521004242	K180485	000
20884521004259	K180485	000
20884521004266	K180485	000
20884521004273	K180485	000
20884521004280	K180485	000
10884521054875	K180485	000