PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH

Catheter, Hemodialysis, Implanted

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Palindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic Cath.

Pre-market Notification Details

• Device ID: K123196
• 510k Number: K123196
• Device Name: PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
• Classification: Catheter, Hemodialysis, Implanted
• Applicant: COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048
• Contact: Jennifer Sullivan
• Correspondent: Jennifer Sullivan; COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048
• Product Code: MSD
• CFR Regulation Number: 876.5540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-10-11
• Decision Date: 2013-01-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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