510(k) K233397
- Device
- Cosine-10TM Diagnostic Catheter
- Applicant
- Medtronic, Inc.
- 510(k) number
- K233397
- Product code
- DRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-02
- Date received
- 2023-10-03
- Regulation
- 870.1220
- Classification name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- 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
- Karine Lortie
- Address
- 8200 Coreal Sea St. NE Mvs3 Mounds View MN US 55112 55112
FDA Registration Numbers
- 2184149
- 1450662
- 9617592
- 1061124
- 2183744
- 2032098
- 3011024991
- 3017060084
- 9610139
- 3014368660
- 1225687
- 1721676
- 2031044
- 3003678543
- 1317547
- 2028523
- 3013162291
- 3025341484
- 2126666
- 2024024
- 1018233
- 2649622
- 3005334138
- 3009254201
- 2184009
- 3009393076
- 3010705768
- 3015537323
- 1028232
- 3010200163
- 3013300026
- 3007616088
- 1928237
- 3009337690
- 3015859709
- 3018258443
- 1319639
- 3027305778
- 3006891611
- 1927197
- 3013403214
- 2648623
- 9673241
- 3013581838
- 2030624
- 3003289723
- 3008497357
- 2032112
- 3009888344
- 9617601
- 3010273872
- 3006634485
- 1650907
- 1643817
- 3019807891
- 2182208
- 3008093809
- 1721686
- 3019751610
- 2029275
- 9681260
- 2024311
- 2124215
- 9680001
- 3012179728
- 3013400708
- 2135338
- 1313046
- 3037050339
- 3032391
- 8043831
- 1721983
- 3011610434
- 2030404
- 9680794
- 3016678045
- 3011276773
- 2182269
- 3004859241
- 3010532612
- 3006082230
- 3008824097
- 1000121056
- 3009243923
- 3008452825
- 2528981
- 3005402529
- 3027815
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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