Synchro2 Support Guidewire
FDA 510(k) clearance K190843 · decided 2019-05-01
Clearance details
- K-number
- K190843
- Device name
- Synchro2 Support Guidewire
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2019-04-01
- Decision date
- 2019-05-01
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MOF
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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