Quadrasphere 30 to 60
FDA 510(k) K113822 · Biosphere Medical, Inc.
510(k) numberK113822
Submission
- Device name
- Quadrasphere 30 to 60
- Applicant
- Biosphere Medical, Inc.
Rockland, MA, US - Received
- December 27, 2011
- Decision date
- March 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was Quadrasphere 30 to 60 cleared by the FDA?
Quadrasphere 30 to 60 (K113822) received a 510(k) decision of Substantially Equivalent on March 8, 2012, 72 days after the submission was received.
What is the product code of K113822?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.