510(k) K180715
- Device
- React 68 Catheter
- Applicant
- Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
- 510(k) number
- K180715
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-04
- Date received
- 2018-03-19
- 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
- Ryan Kenney
- Address
- 9775 Toledo Way Irvine CA US 92618 92618
FDA Registration Numbers#
- 9618000
- 3012266672
- 3009144177
- 3007284313
- 3013944123
- 3016829855
- 1016427
- 3014579161
- 3005941719
- 3014498720
- 2032112
- 3008824097
- 3009380063
- 1000121056
- 3004415014
- 3024801436
- 2134812
- 3010432890
- 3006950086
- 2030598
- 3014590708
- 3011137372
- 3015053858
- 3020954126
- 3002807090
- 3012931345
- 1721686
- 9616666
- 3017708755
- 3012536737
- 3012159165
- 3008814558
- 2024168
- 3000126629
- 1319639
- 3012154226
- 8010026
- 2183870
- 3010882065
- 3009546466
- 3009756153
- 3021951050
- 3010155661
- 2027111
- 1721676
- 1526534
- 3009121749
- 1721504
- 3025028711
- 3013162291
- 1724474
- 3026788751
- 2183744
- 3022392708
- 1928237
- 3010909876
- 3016171942
- 2024311
- 3014461810
- 3016119728
- 3004718255
- 2025870
- 3013556777
- 3012497308
- 3020677060
- 3011142981
- 3014766734
- 1318694
- 3009051888
- 3027343398
- 3032916632
- 1820334
- 3016727301
- 9612164
- 3008264254
- 3032047719
- 3006946276
- 3010419931
- 3014779787
- 9681834
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | 2026-09-18 |
| K260559 | NHanceIT | IMDS Operation B.V. | 2026-08-14 |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026-08-12 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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