510(k) K170616
- Device
- van Andel Dilatation Catheter
- Applicant
- Cook Incorporated
- 510(k) number
- K170616
- Product code
- DRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-28
- Date received
- 2017-03-01
- Regulation
- 870.1310
- Classification name
- Dilator, Vessel, For Percutaneous Catheterization
- 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
- Daniel J. Corbin
- Address
- 750 Daniels Way Bloomington IN US 47404 47404
FDA Registration Numbers
- 3010665433
- 3011468686
- 9616662
- 3011657089
- 3038188187
- 2183744
- 3012536737
- 1644312
- 8010762
- 2032521
- 3031571797
- 3030447506
- 2648727
- 9610139
- 9616099
- 2246552
- 1721676
- 1820334
- 1718850
- 3036802499
- 3007284006
- 3033589330
- 3006950086
- 3025341484
- 3003915875
- 3002807314
- 1018233
- 3005334138
- 1625425
- 3014656749
- 3020778
- 1043214
- 1055236
- 3030714660
- 2953359
- 2522007
- 1722746
- 3007695959
- 1828424
- 1928237
- 1000393132
- 9616683
- 9612126
- 1724474
- 1319639
- 9611665
- 1649395
- 9681477
- 3004784537
- 2032228
- 3003637635
- 3000126629
- 2030624
- 3030446844
- 3027260597
- 3005941719
- 3005580113
- 1000523114
- 3009888344
- 1123137
- 3011642792
- 3018565086
- 3013666336
- 1643817
- 3019807891
- 2182208
- 1721686
- 3019751610
- 2029275
- 9680841
- 3012453745
- 3004111573
- 2124215
- 3008423561
- 1282497
- 2518902
- 3008500478
- 2015691
- 9610849
- 1054241
- 1319211
- 2648045
- 2527072
- 3007146453
- 3011623145
- 3030574705
- 2182269
- 8043892
- 3009211636
- 3015225571
- 3006082230
- 1000121056
- 3015309643
- 3032916632
- 2011171
- 1721504
- 2528981
- 3007882731
- 1016427
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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