ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520

Catheter, Percutaneous

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520.

Pre-market Notification Details

• Device ID: K093050
• 510k Number: K093050
• Device Name: ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
• Classification: Catheter, Percutaneous
• Applicant: ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Christine Ford
• Correspondent: Christine Ford; ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-30
• Decision Date: 2009-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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