510(k) K252533
- Device
- HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- Applicant
- Edwards Lifesciences
- 510(k) number
- K252533
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-18
- Date received
- 2025-08-12
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Niharika Mirji
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers
- 2184149
- 3005877899
- 9710602
- 1218950
- 3007603855
- 3032109181
- 3013627970
- 3001592626
- 1054713
- 3004972322
- 3010342616
- 3012811961
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- 2134265
- 3009092139
- 3012268816
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- 3014271754
- 2183715
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- 2024168
- 9617277
- 2246552
- 2133772
- 1319660
- 2031044
- 3022780114
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- 3030125003
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- 1064858
- 3017233611
- 2126666
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- 1018233
- 9615102
- 3003084417
- 3005334138
- 3017638059
- 3010157426
- 3000279201
- 3009254201
- 3020036682
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- 3004006614
- 3004415095
- 3023164
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- 3008329188
- 3013581838
- 9616760
- 3004105270
- 3010728615
- 3000126629
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- 1721686
- 3017684005
- 3042175841
- 2029275
- 1651104
- 3012154226
- 3024821700
- 1000122786
- 1317188
- 2124215
- 3008012314
- 2952596
- 3012179728
- 3001763079
- 8030978
- 2135338
- 3007029079
- 3008203003
- 3014272734
- 1000165971
- 3008483389
- 2183164
- 3013500228
- 1316463
- 2015691
- 1224919
- 3016674095
- 3021769057
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- 3010089768
- 2030404
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- 3010288146
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- 3012032144
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- 3012359877
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- 3006082230
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- 1527715
- 3026740087
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- 3008452825
- 3022435840
- 2134213
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- 3009600098
- 3012552532
- 3037724692
- 3033558564
- 9681377
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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