MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
FDA 510(k) clearance K123299 · decided 2013-01-18
Clearance details
- K-number
- K123299
- Device name
- MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
- Applicant
- St. Jude Medical Neuromodulation
- Decision
- Substantially Equivalent
- Date received
- 2012-10-23
- Decision date
- 2013-01-18
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. J recall (Z-2718-2014) | St. Jude Medical, Inc. | 2014-09-29 |
| Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. J recall (Z-2719-2014) | St. Jude Medical, Inc. | 2014-09-29 |