510(k) K080360
- Device
- ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
- Applicant
- ENDOLOGIX, INC.
- 510(k) number
- K080360
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-08
- Date received
- 2008-02-11
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNALIZA VICTORIA
- Address
- 11 Studebaker Irvine CA US 92618 92618
FDA Registration Numbers#
- 2184009
- 3008789872
- 3047894544
- 9610139
- 3008627763
- 3009380063
- 9616666
- 3013162291
- 3017210488
- 3005580113
- 3012050423
- 3005334138
- 3039020025
- 9617592
- 1000121056
- 3008423561
- 2029275
- 3004111573
- 3010041511
- 2126666
- 1820334
- 3008700817
- 3010421104
- 1647149
- 3019751610
- 3012154226
- 3007882731
- 3030733800
- 3046434506
- 3005994106
- 1643817
- 2649622
- 3012497308
- 3004718255
- 2020394
- 1048735
- 3035111606
- 1450662
- 3009965866
- 3015309643
- 2134265
- 3010079067
- 3005012805
- 3027319104
- 3009766315
- 1722746
- 9617601
- 3012266672
- 1000563940
- 3010291427
- 3008814558
- 3004784537
- 3015053858
- 1123137
- 3006942602
- 3017168767
- 3009756153
- 1220452
- 3003775186
- 3016522967
- 3020950818
- 9680794
- 3012179728
- 1531050
- 1018233
- 3005232773
- 3024801436
- 3013944123
- 3005941719
- 2020735
- 3010273872
- 3016171942
- 3033589330
- 3008361782
- 3008110587
- 2024024
- 3013764800
- 3039062605
- 1724474
- 3016704395
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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