ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
FDA 510(k) clearance K024118 · decided 2003-02-03
Clearance details
- K-number
- K024118
- Device name
- ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
- Applicant
- Micro Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-16
- Decision date
- 2003-02-03
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow recall (Z-2471-2012) | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 2012-09-27 |