SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
FDA 510(k) clearance K141938 · decided 2015-03-23
Clearance details
- K-number
- K141938
- Device name
- SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
- Applicant
- Terumobct, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-17
- Decision date
- 2015-03-23
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.