Biosphere Medical Infusion Catheter
FDA 510(k) K003105 · Biosphere Medical
510(k) numberK003105
Submission
- Device name
- Biosphere Medical Infusion Catheter
- Applicant
- Biosphere Medical
Rockland, MA, US - Received
- October 4, 2000
- Decision date
- May 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| K113822 | Quadrasphere 30 to 60HCG · Special | 03/08/2012SE |
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| 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 |
| K991549 | Embosphere MicrospheresHCG · Traditional | 04/26/2000SE |
Questions and answers
When was Biosphere Medical Infusion Catheter cleared by the FDA?
Biosphere Medical Infusion Catheter (K003105) received a 510(k) decision of Substantially Equivalent on May 22, 2001, 230 days after the submission was received.
What is the product code of K003105?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.