HYDROFRAME (HES)

Device, Neurovascular Embolization

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydroframe (hes).

Pre-market Notification Details

• Device ID: K090357
• 510k Number: K090357
• Device Name: HYDROFRAME (HES)
• Classification: Device, Neurovascular Embolization
• Applicant: MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408
• Contact: Florin Truuvert
• Correspondent: Florin Truuvert; MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-12
• Decision Date: 2009-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810170013874	K090357	000
00810170015847	K090357	000
00810170015854	K090357	000
00810170019524	K090357	000
00810170019531	K090357	000
00810170019548	K090357	000
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00811425027059	K090357	000
00811425027066	K090357	000
00811425027080	K090357	000
00811425027097	K090357	000
00811425027110	K090357	000
00811425027127	K090357	000
00810170015830	K090357	000
00810170014024	K090357	000
00810170014017	K090357	000
00810170013881	K090357	000
00810170013898	K090357	000
00810170013911	K090357	000
00810170013928	K090357	000
00810170013935	K090357	000
00810170013942	K090357	000
00810170013959	K090357	000
00810170013966	K090357	000
00810170013973	K090357	000
00810170013980	K090357	000
00810170013997	K090357	000
00810170014000	K090357	000
00811425027141	K090357	000
00811425027158	K090357	000
00811425027165	K090357	000
00812636029863	K090357	000
00816777023490	K090357	000
00816777023506	K090357	000
00816777023513	K090357	000
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00816777026576	K090357	000
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00812636029856	K090357	000
00812636029849	K090357	000
00812636029832	K090357	000
00811425027172	K090357	000
00811425027189	K090357	000
00811425027196	K090357	000
00812636023526	K090357	000
00812636023533	K090357	000
00812636029764	K090357	000
00812636029771	K090357	000
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00812636029818	K090357	000
00812636029825	K090357	000
00816777027139	K090357	000