510(k) K070126
- Device
- OCCLUSION BALLOON CATHETER
- Applicant
- SENTREHEART INC.
- 510(k) number
- K070126
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-08
- Date received
- 2007-01-16
- 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
- LINDA GUTHRIE
- Address
- 2468 Embarcadero Way Palo Alto CA US 94303 94303
FDA Registration Numbers#
- 3026788751
- 3015225571
- 2025870
- 3005635992
- 3007628272
- 3012159165
- 3013557562
- 3032277090
- 3007284006
- 3031311812
- 3008307705
- 1061124
- 1820334
- 3009888344
- 3005012805
- 3006451981
- 3012494290
- 3009018440
- 3012279212
- 3010370269
- 3007284313
- 3020677060
- 2182208
- 3007740583
- 1319639
- 3027319104
- 3003610571
- 3004415014
- 1220452
- 3012931345
- 2029214
- 2124215
- 3016444913
- 3046434506
- 3038912532
- 1526863
- 2030598
- 3001374820
- 3012050423
- 1721686
- 1061927
- 1220477
- 3007882731
- 3008853977
- 1318694
- 2528981
- 3010419931
- 2024311
- 1018233
- 3015970743
- 3005941719
- 3006946276
- 1058584
- 3017262662
- 3012543881
- 3015053858
- 2649622
- 3030088112
- 3011137372
- 3012448339
- 1828132
- 3031768596
- 3016119728
- 3020954126
- 3030236028
- 3013758550
- 3039020025
- 3020347218
- 3006950086
- 3047894544
- 9617601
- 2518902
- 3006131984
- 1118880
- 3015550451
- 2135147
- 3019751610
- 3013288201
- 3000308637
- 3033589330
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
Legacy Summary#
summary
FDA Review#
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