ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER

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

ARROW INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Arrow, Arrowg+ard And Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter.

Pre-market Notification Details

• Device ID: K071538
• 510k Number: K071538
• Device Name: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. PO BOX 12888 Reading, PA 19612 -2888
• Contact: Kirsten Stowell
• Correspondent: Kirsten Stowell; ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. PO BOX 12888 Reading, PA 19612 -2888
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-05
• Decision Date: 2007-08-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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