ARROW PICC POWERED BY ARROW VPS STYLET

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

ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)

The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Arrow Picc Powered By Arrow Vps Stylet.

Pre-market Notification Details

• Device ID: K121941
• 510k Number: K121941
• Device Name: ARROW PICC POWERED BY ARROW VPS STYLET
• Classification: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
• Applicant: ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Elizabeth Duncan
• Correspondent: Elizabeth Duncan; ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605
• Product Code: LJS
• CFR Regulation Number: 880.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-02
• Decision Date: 2012-09-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10801902076486	K121941	000
20801902130284	K121941	000
40801902127059	K121941	000
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