510(k) K200417
- Device
- RIST Radial Access Catheter
- Applicant
- RIST Neurovascular, Inc.
- 510(k) number
- K200417
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-02
- Date received
- 2020-02-20
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marianne Grumwaldt
- Address
- 11611 Interchange Cir. S. Miramar FL US 33025 33025
FDA Registration Numbers#
- 1035166
- 3017636737
- 2027062
- 9617601
- 1064858
- 2024311
- 3008264254
- 2183744
- 3009546466
- 3004063494
- 3017210488
- 3011370111
- 3014779787
- 3000308637
- 1220477
- 3014590708
- 3014758755
- 3013656790
- 3015701715
- 3003780911
- 3014211783
- 3007007790
- 3017278832
- 3024801436
- 3020954126
- 3031768596
- 3025028711
- 3006451981
- 3027319104
- 3009965866
- 3014644549
- 3009057691
- 3002807314
- 3015550451
- 3019807891
- 3014162263
- 1721676
- 3007628272
- 3010079067
- 3030088112
- 3013758550
- 3005168196
- 3013858269
- 3016591327
- 3031311812
- 2029214
- 3015453963
- 3006010712
- 3009380063
- 3017168767
- 3008114965
- 3016800412
- 2030624
- 1047843
- 3014498720
- 3016522967
- 2011171
- 3009337401
- 3012497308
- 3008837339
- 3012543881
- 1048735
- 3013944123
- 3003775027
- 3032047719
- 3008881809
- 3008824097
- 3015615738
- 3008853977
- 3012931345
- 3013556777
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases