PRESSURE INJFECTABLE PICC

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

ARROW INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Pressure Injfectable Picc.

Pre-market Notification Details

• Device ID: K080604
• 510k Number: K080604
• Device Name: PRESSURE INJFECTABLE PICC
• Classification: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
• Applicant: ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Julie Lawson
• Correspondent: Julie Lawson; ARROW INTERNATIONAL, 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: 2008-03-04
• Decision Date: 2008-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10801902095494	K080604	000
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