TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT

Introducer, Catheter

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Two-lumen Central Venous Access Kit With Hemostasis Valve/side Port.

Pre-market Notification Details

• Device ID: K002507
• 510k Number: K002507
• Device Name: TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
• Classification: Introducer, Catheter
• Applicant: ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Thomas D Nickel
• Correspondent: Thomas D Nickel; ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-15
• Decision Date: 2001-03-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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