ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE

Drape, Surgical

ANGIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Angiosys Femoral Angiography Drape.

Pre-market Notification Details

• Device ID: K843260
• 510k Number: K843260
• Device Name: ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
• Classification: Drape, Surgical
• Applicant: ANGIOSYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KKX
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-08-20
• Decision Date: 1984-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00816611021187	K843260	000
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