NEURON DELIVERY CATHETER 070
FDA 510(k) clearance K082290 · decided 2008-10-31
Clearance details
- K-number
- K082290
- Device name
- NEURON DELIVERY CATHETER 070
- Applicant
- Penumbra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-11
- Decision date
- 2008-10-31
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058 recall (Z-0001-2010) | Penumbra Inc. | 2009-10-05 |