Embosphere Microspheres
FDA 510(k) K991549 · Biosphere Medical
510(k) numberK991549
Submission
- Device name
- Embosphere Microspheres
- Applicant
- Biosphere Medical
Rockland, MA, US - Received
- May 3, 1999
- Decision date
- April 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K113822 | Quadrasphere 30 to 60HCG · Special | 03/08/2012SE |
| K052742 | Hepasphere MicrospheresKRD · Traditional | 11/07/2006SE |
| K062126 | Embocath Plus Infusion Microcatheter, Model ECP-100 and ECP-135DQO · Special | 08/09/2006SE |
| K061171 | Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXDQX · Traditional | 06/02/2006SE |
| K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationNAJ · Traditional | 11/22/2002SE |
| K010026 | Embogold MicrosphereHCG · Special | 06/21/2001SE |
| K003105 | Biosphere Medical Infusion CatheterDQO · Traditional | 05/22/2001SE |
Questions and answers
When was Embosphere Microspheres cleared by the FDA?
Embosphere Microspheres (K991549) received a 510(k) decision of Substantially Equivalent on April 26, 2000, 359 days after the submission was received.
What is the product code of K991549?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.