VPS Rhythm Device With TipTracker Technology

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)

The following data is part of a premarket notification filed by Arrow International, Inc. (a Subsidiary Of Teleflex, Inc.) with the FDA for Vps Rhythm Device With Tiptracker Technology.

Pre-market Notification Details

• Device ID: K160925
• 510k Number: K160925
• Device Name: VPS Rhythm Device With TipTracker Technology
• Classification: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
• Applicant: ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Karl J. Nittinger
• Correspondent: Christine Ford; ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE RD. Reading, PA 19605
• Product Code: LJS
• CFR Regulation Number: 880.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-04
• Decision Date: 2016-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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