NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
FDA 510(k) clearance K070970 · decided 2007-08-17
Clearance details
- K-number
- K070970
- Device name
- NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
- Applicant
- Penumbra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-06
- Decision date
- 2007-08-17
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Leandro, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., A recall (Z-2313-2009) | Penumbra Inc. | 2009-09-24 |