MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
FDA 510(k) clearance K034036 · decided 2004-02-13
Clearance details
- K-number
- K034036
- Device name
- MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
- Applicant
- Micro Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-29
- Decision date
- 2004-02-13
- Days to decision
- 46 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow D recall (Z-2472-2012) | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 2012-09-27 |