CELT ACD VASCULAR CLOSURE DEVICE
Vasorum, Ltd. · Device, hemostasis, vascular · Cardiovascular
Open FDA's page for this record- PMA number
- P150006
- Supplement number
- S009
- Applicant
- Vasorum, Ltd.
- Street 1
- 2012 Orchard Ave.
- Street 2
- Citywest Business Campus
- City
- Dublin
- Zip
- 24
- Generic name
- Device, hemostasis, vascular
- Trade name
- CELT ACD VASCULAR CLOSURE DEVICE
- Product code
- MGB
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited review flag
- N
- Date received
- 2026-10-02
- Decision date
- 2026-10-30
- Decision code
- APPR
- Ao statement
- changes to the Instructions for Use labeling for a limited number of CELT ACD PLUS 5F device lots
- Harmonized identifiers (openFDA)
- Device name
- Device, Hemostasis, Vascular
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3005718570, 2953359, 2939561, 1016427, 3015145497, 1649518, 3015542130, 3007766601, 2011171, 3003898360, 2029275, 2134812, 3011137372, 2246552, 1721686, 1118880, 3009984513, 3004939290, 2022435, 2024168, 3011469355, 3012977275, 9616099, 3008102042, 3008307705, 3012102437, 1423662, 3005334138, 3002907620, 2183744, 1226183, 2243441, 3004091615, 3002807314, 3013394970, 3012448339
- FEI number
- 3005718570, 1016427, 3015145497, 3015542130, 3007766601, 2011171, 3003898360, 3000215205, 3002924544, 3000215273, 3010142363, 3001236277, 1000306431, 3004635528, 1721686, 1118880, 3009984513, 2246552, 2022435, 2024168, 3011469355, 3012977275, 3008307705, 3002757549, 3012102437, 3003528016, 3005747797, 3005334138, 3002907620, 3002827704, 2183744, 2243441, 3004091615, 3002807314, 3013394970, 3012448339