MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MedSource International, LLC

The following data is part of a premarket notification filed by Medsource International, Llc with the FDA for Medsource Truesafe Safety Iv Catheter, Medsource Truesafe Comfort Safety Iv Catheter.

Pre-market Notification Details

• Device ID: K161779
• 510k Number: K161779
• Device Name: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: MedSource International, LLC 401 Norex Drive Chaska, MN 55318
• Contact: Laura Riggen
• Correspondent: Laura Riggen; MedSource International, LLC 401 Norex Drive Chaska, MN 55318
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-29
• Decision Date: 2016-11-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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