Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known AS the Trufill DCS Orbit
FDA 510(k) K080967 · Cordis Neurovascular, Inc.
510(k) numberK080967
Submission
- Device name
- Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known AS the Trufill DCS Orbit
- Applicant
- Cordis Neurovascular, Inc.
Miami Lakes, FL, US - Received
- April 4, 2008
- Decision date
- May 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
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| 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 |
| 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 |
| K063254 | The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | 12/07/2006SE |
| 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 Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known AS the Trufill DCS Orbit cleared by the FDA?
Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known AS the Trufill DCS Orbit (K080967) received a 510(k) decision of Substantially Equivalent on May 2, 2008, 28 days after the submission was received.
What is the product code of K080967?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.