FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
FDA 510(k) clearance K033569 · decided 2004-01-13
Clearance details
- K-number
- K033569
- Device name
- FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
- Applicant
- Flowmedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-12
- Decision date
- 2004-01-13
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion syst recall (Z-1733-2010) | Angiodynamics, Inc. | 2010-05-28 |
| ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion syst recall (Z-1734-2010) | Angiodynamics, Inc. | 2010-05-28 |