Microplex Coil Systems (MCS)
FDA 510(k) K021914 · MicroVention, Inc.
510(k) numberK021914
Submission
- Device name
- Microplex Coil Systems (MCS)
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- June 11, 2002
- Decision date
- July 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | 06/13/2025SE |
| K232542 | Wedge XL Delivery CatheterQJP · Traditional | 05/16/2024SE |
| K230775 | SOFIA EX Intracranial Support CatheterQJP · Traditional | 09/14/2023SE |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | 04/27/2023SE |
| K222115 | ISAAC Neurovascular Navigation CatheterDQY · Traditional | 01/10/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
| K214024 | SOFIA 88 CatheterDQY · Traditional | 09/12/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | 03/31/2022SE |
| K193607 | BOBBY Balloon Guide CatheterDQY · Traditional | 07/21/2020SE |
| K201487 | Traxcess 7 Mini GuidewireMOF · Special | 07/02/2020SE |
Questions and answers
When was Microplex Coil Systems (MCS) cleared by the FDA?
Microplex Coil Systems (MCS) (K021914) received a 510(k) decision of Substantially Equivalent on July 9, 2002, 28 days after the submission was received.
What is the product code of K021914?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.