Micrus Microcoil System
FDA 510(k) K070707 · Micrus Endovascular Corporation
510(k) numberK070707
Submission
- Device name
- Micrus Microcoil System
- Applicant
- Micrus Endovascular Corporation
San Jose, CA, US - Received
- March 14, 2007
- Decision date
- April 6, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
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| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
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| K092702 | Micrus Microcatheter, Model Courier 270DQO · Special | 11/20/2009SE |
| K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…MJN · Special | 06/19/2009SE |
| K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00DQO · Special | 05/06/2009SE |
| K090274 | Micrus One 2 One Guidewire and Soft GuidewireDQX · Special | 03/03/2009SE |
| K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPLHCG · Special | 01/02/2009SE |
| K082739 | Micrus Microcoil Delivery SystemHCG · Special | 10/17/2008SE |
| K080861 | Micrus Ascent Occlusion Balloon CatheterMJN · Traditional | 08/27/2008SE |
| K080379 | Micrus Microcoil System, Deltapaq 10 Stretch ResistantHCG · Traditional | 06/30/2008SE |
Questions and answers
When was Micrus Microcoil System cleared by the FDA?
Micrus Microcoil System (K070707) received a 510(k) decision of Substantially Equivalent on April 6, 2007, 23 days after the submission was received.
What is the product code of K070707?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.