Radiopaque Spherical Emboli (Rse)
FDA 510(k) K871047 · Interventional Therapeutics Corp.
510(k) numberK871047
Submission
- Device name
- Radiopaque Spherical Emboli (Rse)
- Applicant
- Interventional Therapeutics Corp.
Santa Barbara, CA, US - Received
- March 17, 1987
- Decision date
- May 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K960832 | Occlusion Balloon CatheterMJN · Traditional | 05/29/1996SE |
| K950398 | Catheter, Balloon TypeDQO · Traditional | 10/05/1995SE |
| K945588 | Disposable 1CC Syringe with Luer LockFMF · Traditional | 02/10/1995SE |
| K944354 | Contour EmboliHCG · Traditional | 12/13/1994SE |
| K930456 | Intherm Single-Stick Radially Expanding DilatorKNT · Traditional | 11/17/1993SE |
| K914866 | Itc Contour Emboli, ModificationHCG · Traditional | 11/09/1993SE |
| K931025 | Intherm Stasis Valve SystemFGE · Traditional | 09/28/1993SE |
| K931278 | Intherm Single-Stick Radially Expanding DilatorGCJ · Traditional | 07/23/1993SE |
| K922609 | Itc Catheters W/ HydromerDQY · Traditional | 04/30/1993SE |
| K925876 | Itc Bunji Platinum Embolization CoilHCG · Traditional | 04/15/1993SE |
Questions and answers
When was Radiopaque Spherical Emboli (Rse) cleared by the FDA?
Radiopaque Spherical Emboli (Rse) (K871047) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 66 days after the submission was received.
What is the product code of K871047?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.