Prestige Coil System

Device, Vascular, For Promoting Embolization

Bait USA, LLC

The following data is part of a premarket notification filed by Bait Usa, Llc with the FDA for Prestige Coil System.

Pre-market Notification Details

• Device ID: K220699
• 510k Number: K220699
• Device Name: Prestige Coil System
• Classification: Device, Vascular, For Promoting Embolization
• Applicant: Bait USA, LLC 29 Parker Irvine, CA 92618
• Contact: Michael Peters
• Correspondent: Michael Peters; Bait USA, LLC 29 Parker Irvine, CA 92618
• Product Code: KRD
• CFR Regulation Number: 870.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-10
• Decision Date: 2022-04-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810068567304	K220699	000
00810068567465	K220699	000
00810068567472	K220699	000
00810068567489	K220699	000
00810068567496	K220699	000
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00810068567793	K220699	000
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00810068567625	K220699	000
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00810068567670	K220699	000
00810068567687	K220699	000
00810068567694	K220699	000
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00810068567731	K220699	000
00810068568042	K220699	000