Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
FDA 510(k) clearance K180574 · decided 2018-08-17
Clearance details
- K-number
- K180574
- Device name
- Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
- Applicant
- J & J Solutions, Inc. D/B/A/ Corvida Medical
- Decision
- Substantially Equivalent
- Date received
- 2018-03-05
- Decision date
- 2018-08-17
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- ONB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Eagan, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.