PERCUTANEOUS SHEATH INTRODUCER KIT

Introducer, Catheter

ARROW INTL., INC.

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

Pre-market Notification Details

• Device ID: K780532
• 510k Number: K780532
• Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Classification: Introducer, Catheter
• Applicant: ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Correspondent: ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-04-04
• Decision Date: 1978-04-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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