CodMan Certas Plus Programmable Valve
FDA 510(k) clearance K182265 · decided 2018-11-20
Clearance details
- K-number
- K182265
- Device name
- CodMan Certas Plus Programmable Valve
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-21
- Decision date
- 2018-11-20
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.