ClearLine IV
FDA 510(k) clearance K171954 · decided 2018-01-25
Clearance details
- K-number
- K171954
- Device name
- ClearLine IV
- Applicant
- Clearline MD
- Decision
- Substantially Equivalent
- Date received
- 2017-06-29
- Decision date
- 2018-01-25
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- OKL
- Device class
- 2
- Regulation number
- 880.5445
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| AIRPURGE (DEN080009) | Anesthesia Safety Products, LLC | 2014-03-04 |
Recalls involving this device
No recalls on record reference this clearance.