510(k) K240018
- Device
- WATCHMAN TruSteer Access System (M635TU90050)
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K240018
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-01
- Date received
- 2024-01-02
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Alexa Keenan
- Address
- 300 Boston Scientific Way Marborough MA US 01752 01752
FDA Registration Numbers
- 3000247873
- 3008573567
- 1722746
- 1000563940
- 3007882731
- 3012050423
- 1318694
- 1028232
- 9617601
- 2024311
- 3039062605
- 3006425876
- 3007113487
- 3003898360
- 2029275
- 2024024
- 3007284006
- 2528981
- 3013288201
- 3005635992
- 3014656749
- 3017708755
- 9614654
- 3012266672
- 9612164
- 9618000
- 3003775186
- 3031768596
- 3011088743
- 2017865
- 3009965866
- 3002807314
- 3010882065
- 1118880
- 9616099
- 1625425
- 1531050
- 3021951050
- 3007628272
- 3030088112
- 1000121056
- 3012154226
- 3006550224
- 2184009
- 3008627763
- 3016591327
- 3017168767
- 3027058844
- 3006260740
- 3013162291
- 2032112
- 1047843
- 2011171
- 3009144177
- 3004784537
- 9610139
- 3005232773
- 3012497308
- 1048735
- 3016444913
- 1319639
- 2126666
- 3003775027
- 3032047719
- 1018233
- 3008853977
- 1928237
- 3016540856
- 3008700817
- 3012931345
- 2182208
- 3003915875
- 3002807090
- 2135147
- 1225687
- 1018470
- 3011706110
- 3038912532
- 3009756327
Source Documents
Other 510(k) Records For Product Code DQY
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|---|---|---|---|
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | 2026-03-13 |
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| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 |