ARROW RADIAL ARTERY CATHETERIZATION SET

Wire, Guide, Catheter

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Radial Artery Catheterization Set.

Pre-market Notification Details

• Device ID: K810675
• 510k Number: K810675
• Device Name: ARROW RADIAL ARTERY CATHETERIZATION SET
• Classification: Wire, Guide, 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: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-03-12
• Decision Date: 1981-03-27

NIH GUDID Devices

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