HYDROCOIL EMBOLIC SYSTEM (HES)

Device, Neurovascular Embolization

MICROVENTION, INC.

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

Pre-market Notification Details

• Device ID: K113457
• 510k Number: K113457
• Device Name: HYDROCOIL EMBOLIC SYSTEM (HES)
• Classification: Device, Neurovascular Embolization
• Applicant: MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780
• Contact: Laraine Pangelina
• Correspondent: Laraine Pangelina; MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-22
• Decision Date: 2011-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810170017100	K113457	000
00810170017391	K113457	000
00811425026816	K113457	000
00811425026830	K113457	000
00811425026847	K113457	000
00811425026854	K113457	000
00811425026861	K113457	000
00811425026878	K113457	000
00811425026885	K113457	000
00811425026892	K113457	000
00811425026908	K113457	000
00811425026915	K113457	000
00811425026922	K113457	000
00811425026939	K113457	000
00811425026946	K113457	000
00810170017384	K113457	000
00810170017377	K113457	000
00810170017360	K113457	000
00810170017209	K113457	000
00810170017223	K113457	000
00810170017247	K113457	000
00810170017254	K113457	000
00810170017261	K113457	000
00810170017278	K113457	000
00810170017285	K113457	000
00810170017292	K113457	000
00810170017308	K113457	000
00810170017315	K113457	000
00810170017322	K113457	000
00810170017339	K113457	000
00810170017346	K113457	000
00810170017353	K113457	000
00811425026953	K113457	000
00811425026960	K113457	000
00811425026977	K113457	000
00812636029689	K113457	000
00812636029696	K113457	000
00812636029702	K113457	000
00812636029719	K113457	000
00812636029726	K113457	000
00812636029733	K113457	000
00816777023308	K113457	000
00816777023315	K113457	000
00816777023322	K113457	000
00816777023339	K113457	000
00816777024404	K113457	000
00816777024411	K113457	000
00816777024428	K113457	000
00816777024435	K113457	000
00812636029672	K113457	000
00812636029665	K113457	000
00812636029658	K113457	000
00811425026984	K113457	000
00811425026991	K113457	000
00811425027004	K113457	000
00811425027011	K113457	000
00812636029535	K113457	000
00812636029559	K113457	000
00812636029566	K113457	000
00812636029580	K113457	000
00812636029597	K113457	000
00812636029603	K113457	000
00812636029610	K113457	000
00812636029627	K113457	000
00812636029634	K113457	000
00812636029641	K113457	000
00816777027238	K113457	000