510(k) K243224
- Device
- MitraClip? G5 Steerable Guide Catheter (SGC0801); TriClip? G5 Steerable Guide Catheter (TSGC0801)
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K243224
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-31
- Date received
- 2024-10-07
- 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
- Vidya Thyagarajan
- Address
- 177 County Rd. B E. St. Paul MN US 55117 55117
FDA Registration Numbers#
- 3038912532
- 1526863
- 3009965866
- 2523676
- 2027062
- 3013858269
- 3006946276
- 3008824097
- 2939561
- 3006550224
- 9618000
- 3031768596
- 3033589330
- 3012931345
- 2025870
- 9614654
- 3012159165
- 3030236028
- 2024311
- 9610139
- 3015970743
- 3008261722
- 3009766315
- 9612164
- 3027319104
- 1450662
- 2184009
- 3016948450
- 9616666
- 3008853977
- 2032112
- 3009051888
- 2648729
- 2649622
- 1820334
- 3008307705
- 2134265
- 3009756327
- 3000126629
- 3030733800
- 1721686
- 3031311812
- 3007882731
- 3010419931
- 3008627763
- 1123137
- 3012050423
- 3009121749
- 3001124136
- 3004718255
- 3015615738
- 3012179728
- 3009546466
- 3039020025
- 3008573567
- 1048735
- 1721676
- 8043892
- 3013162291
- 3005168196
- 3004415014
- 3030088112
- 3013288201
- 1313046
- 1000121056
- 2126666
- 3003775027
- 3015060261
- 3002807314
- 3006950086
- 3016444913
- 3012307300
- 1647149
- 3014766734
- 3005232773
- 2024168
- 3012536737
- 8023054
- 3014687026
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 |