510(k) K121219
- Device
- ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
- Applicant
- MEDTRONIC INC.
- 510(k) number
- K121219
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-25
- Date received
- 2012-04-23
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WENDY SAUNDERS
- Address
- 8200 Coral Sea St. Ms Mvsii Mounds View MN US 55112 55112
FDA Registration Numbers#
- 3015060261
- 9681477
- 1016427
- 2017865
- 3005070406
- 3003610571
- 3012448339
- 3008853977
- 2135147
- 3020954126
- 1048735
- 1531050
- 3015053858
- 3015309643
- 1047843
- 1313046
- 1647149
- 3039020025
- 3017708755
- 3009564766
- 2183787
- 3002807314
- 1721504
- 3032277090
- 3022392708
- 3003915875
- 2025870
- 3013162291
- 2032112
- 9617601
- 3005168196
- 1625425
- 1319639
- 1721676
- 3027319104
- 3004859241
- 9616684
- 3008114965
- 3015002281
- 8010026
- 3006950086
- 2027062
- 2518902
- 3016444913
- 3004091615
- 3007284006
- 3015225571
- 9681834
- 3038912532
- 3027058844
- 3011706110
- 3009380063
- 3009965866
- 1018470
- 3013858269
- 1000121056
- 9612164
- 3009546466
- 3020677060
- 3008264254
- 3009888344
- 3006942602
- 1646831
- 3010291427
- 9616099
- 3013758550
- 3012536737
- 2126666
- 2020394
- 3044156918
- 3035111606
- 1526863
- 3005334138
- 3009766315
- 3017168767
- 2528981
- 3025341484
- 3001124136
- 2939561
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 |
| 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 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 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 |
Legacy Summary#
summary
FDA Review#
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