Target Detachable Coil
FDA 510(k) K113412 · Stryker Neurovascular
510(k) numberK113412
Submission
- Device name
- Target Detachable Coil
- Applicant
- Stryker Neurovascular
Fremont, CA, US - Received
- November 18, 2011
- Decision date
- December 13, 2011
- 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 |
|---|---|---|
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | 07/01/2026SE |
| K253032 | AXS Lift Intracranial Base CatheterQJP · Traditional | 02/11/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | 10/17/2025SE |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…QJP · Special | 03/21/2025SE |
| K243593 | AXS Lift Intracranial Base CatheterQJP · Traditional | 02/18/2025SE |
| K241768 | Broadway 8 CatheterQJP · Traditional | 12/19/2024SE |
| K241637 | Echo Intracranial Base CatheterQJP · Traditional | 12/19/2024SE |
| K223305 | Trevo NXT ProVue RetrieverPOL · Traditional | 03/29/2023SE |
| K222533 | Target Tetra Detachable CoilsHCG · Traditional | 12/14/2022SE |
Questions and answers
When was Target Detachable Coil cleared by the FDA?
Target Detachable Coil (K113412) received a 510(k) decision of Substantially Equivalent on December 13, 2011, 25 days after the submission was received.
What is the product code of K113412?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.