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
20801902125501	K160925	000
20801902132851	K160925	000
20801902132844	K160925	000
20801902132837	K160925	000
20801902125693	K160925	000
20801902125686	K160925	000
20801902125679	K160925	000
20801902125662	K160925	000
20801902125655	K160925	000
20801902125648	K160925	000
20801902132868	K160925	000
20801902132875	K160925	000
20801902132882	K160925	000
10801902127898	K160925	000
20801902162612	K160925	000
60801902123789	K160925	000
10801902168662	K160925	000
10801902168655	K160925	000
20801902169925	K160925	000
20801902169918	K160925	000
10801902114607	K160925	000
20801902125235	K160925	000
20801902125556	K160925	000
20801902125549	K160925	000
20801902125532	K160925	000
20801902198598	K160925	000
20801902188377	K160925	000
20801902188360	K160925	000
20801902186816	K160925	000
20801902195917	K160925	000
20801902195900	K160925	000
20801902198116	K160925	000
20801902198109	K160925	000
20801902198093	K160925	000
20801902194293	K160925	000
20801902194309	K160925	000
20801902192558	K160925	000
20801902125525	K160925	000
20801902125518	K160925	000
20801902125396	K160925	000
20801902125389	K160925	000
20801902125372	K160925	000
20801902125365	K160925	000
20801902125358	K160925	000
20801902125341	K160925	000
20801902192565	K160925	000
20801902197812	K160925	000
10801902127881	K160925	000
50801902132876	K160925	000
40801902132862	K160925	000
40801902132855	K160925	000
40801902132848	K160925	000
40801902132831	K160925	000
40801902125697	K160925	000
40801902125666	K160925	000
40801902125659	K160925	000
40801902125642	K160925	000
40801902125543	K160925	000
40801902132879	K160925	000
40801902132886	K160925	000
30801902125355	K160925	000
60801902132866	K160925	000
60801902132859	K160925	000
60801902132842	K160925	000
30801902132834	K160925	000
30801902125683	K160925	000
30801902125676	K160925	000
30801902125553	K160925	000
30801902125539	K160925	000
30801902125522	K160925	000
40801902125512	K160925	000
40801902125390	K160925	000
40801902125383	K160925	000
20801902157625	K160925	000
20801902157618	K160925	000
20801902157601	K160925	000
10801902114638	K160925	000
20801902125945	K160925	000
20801902114659	K160925	000
10801902124798	K160925	000
10801902114614	K160925	000
20801902160809	K160925	000
20801902157571	K160925	000
20801902157588	K160925	000
20801902157595	K160925	000
40801902125376	K160925	000
40801902125369	K160925	000
40801902125345	K160925	000
20801902125242	K160925	000
20801902125228	K160925	000
20801902145202	K160925	000
20801902145196	K160925	000
20801902143116	K160925	000
20801902143109	K160925	000
20801902127895	K160925	000