ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

Introducer, Catheter

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Percutaneous Sheath Introducer Kit Ak-07903.

Pre-market Notification Details

• Device ID: K940079
• 510k Number: K940079
• Device Name: ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
• Classification: Introducer, Catheter
• Applicant: ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605
• Contact: Thomas D Nickel
• Correspondent: Thomas D Nickel; ARROW INTL., INC. 3000 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: 1994-01-07
• Decision Date: 1994-11-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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