510(k) K163000
- Device
- AMPLATZER TorqVue 45x45 Delivery Sheath
- Applicant
- AGA Medical Corporation (Wholly Owned By St. Jude Medical Co
- 510(k) number
- K163000
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-23
- Date received
- 2016-10-28
- 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
Applicant Contact#
- Contact
- Mary Johnson
- Address
- 5050 Nathan Ln. Plymouth MN US 55442 55442
FDA Registration Numbers#
- 3025341484
- 3006131984
- 3006950086
- 1061124
- 3012179728
- 3008110587
- 2648045
- 3009766315
- 3010155661
- 3033589330
- 3032916632
- 2134265
- 1526534
- 3011088743
- 9616684
- 3002807314
- 3002806603
- 2528981
- 2024311
- 3013858269
- 3010370269
- 3005255160
- 2182208
- 1721676
- 3008264254
- 3014162263
- 3003780911
- 3006550224
- 3006425876
- 3003610571
- 2183787
- 3011137372
- 3010419931
- 2024168
- 3016678045
- 1028232
- 1647149
- 3004742232
- 3038912532
- 3008824097
- 3013288201
- 9614654
- 3012050423
- 3001374820
- 3014656749
- 3016829855
- 3020347218
- 1123137
- 3001124136
- 3020954126
- 3012497308
- 3006946276
- 3020950818
- 3014461810
- 3008114965
- 3014579161
- 8010026
- 3000308637
- 3010882065
- 1722746
- 3007284313
- 2011171
- 3009144177
- 3008881809
- 3009546466
- 9616099
- 3016522967
- 3031768596
- 2020394
- 3003775027
- 2027111
- 2017233
- 2027062
- 2183744
- 3013134719
- 3008261722
- 2184009
- 3009564766
- 1016427
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 |
| 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 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
| 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 |
Legacy Summary#
summary
FDA Review#
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