VueJect® Ultrasound Enhancing Agent Delivery System
ACIST Medical Systems, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- Y
- City
- Eden Prairie
- Advisory committee description
- Cardiovascular
- Address 1
- 7905 Fuller Rd.
- Statement or summary
- Summary
- Product code
- IZQ
- Zip code
- 55344
- Applicant
- ACIST Medical Systems, Inc.
- Decision date
- 2026-08-03
- Decision code
- SESE
- Country code
- US
- Device name
- VueJect® Ultrasound Enhancing Agent Delivery System
- Advisory committee
- CV
- Contact
- Linda Busklein
- K number
- K262115
- State
- MN
- Date received
- 2026-06-23
- Review advisory committee
- HO
- Postal code
- 55344
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Injector, Contrast Medium, Automatic
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1650
- Device class
- 2
- Registration number
- 9616567, 3003786696, 3004056159, 3023851856, 1054713, 3010173425, 1038185, 2029275, 3002807314, 3009882464, 3009756327, 3011816507, 3004050971, 3012085143, 3006174295, 3003366417, 1526534, 3005441393, 1000604079, 3030656768, 3001427085, 3002806603, 3012529833, 3010374357, 3006617533, 3011334555, 9612420, 2520313, 1058584, 1518293, 2134243, 3040111919, 3006791331, 3015276088, 8020864, 3010160527, 3010155661, 3002808022, 1319639, 3012044688 +3 more
- FEI number
- 3002807036, 3003786696, 1000306431, 3004056159, 3023851856, 3005737257, 3002807038, 1038185, 3002807314, 3009882464, 3011816507, 3012085143, 3004050971, 3001726808, 3006174295, 1000114111, 3002807156, 3003366417, 1526534, 3005441393, 1000604079, 3030656768, 3001427085, 3002806603, 1000219637, 3012529833, 3010374357, 3006617533, 3011334555, 2520313, 1518293, 3040111919, 3006791331, 3002807040, 3015276088, 3002808022, 3010155661, 1000138054, 3012044688, 3002963732 +3 more