Sapphire Sets
FDA 510(k) clearance K171346 · decided 2017-08-25
Clearance details
- K-number
- K171346
- Device name
- Sapphire Sets
- Applicant
- Icu Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-05-08
- Decision date
- 2017-08-25
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.