The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System
FDA 510(k) K063254 · Cordis Neurovascular, Inc.
510(k) numberK063254
Submission
- Device name
- The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System
- Applicant
- Cordis Neurovascular, Inc.
Miami Lake, FL, US - Received
- October 27, 2006
- Decision date
- December 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K082324 | Trufill DCS SyringeHCG · Special | 09/12/2008SE |
| K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…HCG · Special | 05/02/2008SE |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)HCG · Special | 09/26/2007SE |
| K070279 | Modification to Hypertransit Infusion CatheterKRA · Special | 03/14/2007SE |
| K053197 | Trufill DCS Orbit Detachable Coil System Line ExtensionHCG · Special | 12/15/2005SE |
| K043538 | Hypertransit Infusion CatheterKRA · Traditional | 04/18/2005SE |
| K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS Trufill DCS…HCG · Special | 09/23/2003SE |
| K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS the Trufill DCS…HCG · Traditional | 06/20/2003SE |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | 05/22/2002SE |
| K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | 03/27/2002SE |
Questions and answers
When was The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System cleared by the FDA?
The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil System (K063254) received a 510(k) decision of Substantially Equivalent on December 7, 2006, 41 days after the submission was received.
What is the product code of K063254?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.