Micrus Microcoil System
FDA 510(k) K032872 · Micrus Corp.
510(k) numberK032872
Submission
- Device name
- Micrus Microcoil System
- Applicant
- Micrus Corp.
Sunnyvale, CA, US - Received
- September 15, 2003
- Decision date
- November 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261772 | Target Xtra Detachable CoilHCG · Special | Stryker Neurovscular | 06/24/2026SE |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | Stryker Neurovascular | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | Stryker Neurovascular | 10/17/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| 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 |
More from Stryker Neurovscular
| 510(k) | Device | Decision |
|---|---|---|
| K033813 | Micrus Modified Microcoil System, CerecyteHCG · Traditional | 02/04/2004SE |
| K032624 | Micrus MicrocatheterDQO · Traditional | 09/10/2003SE |
| K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRHCG · Traditional | 08/01/2003SE |
| K022420 | Micrus Stretch-Resistant Microcoil System, MSR01HCG · Traditional | 10/22/2002SE |
| K002056 | Micrus Microcoil Delivery System, MDS03HCG · Traditional | 01/11/2001SE |
Questions and answers
When was Micrus Microcoil System cleared by the FDA?
Micrus Microcoil System (K032872) received a 510(k) decision of Substantially Equivalent on November 28, 2003, 74 days after the submission was received.
What is the product code of K032872?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.