SmartSite Vented Vial Access Device
FDA 510(k) clearance K151963 · decided 2015-07-31
Clearance details
- K-number
- K151963
- Device name
- SmartSite Vented Vial Access Device
- Applicant
- Yukon Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-07-16
- Decision date
- 2015-07-31
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Durham, NC, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Yukon Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.