510(k) K991601
- Device
- DUAL LUMEN CATHETER, MODEL DL-35-90
- Applicant
- ENDOLOGIX, INC.
- 510(k) number
- K991601
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-10-28
- Date received
- 1999-05-10
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN U SALINAS
- Address
- 20 Fairbanks, Suite #173 Irvine CA US 92618 92618
FDA Registration Numbers#
- 3013758550
- 3007740583
- 3010421104
- 3004742232
- 1000563940
- 3007628272
- 3005718570
- 3030236028
- 1016427
- 3006131984
- 3044156918
- 1061927
- 3003780911
- 3015002281
- 1018470
- 1118880
- 9618000
- 3002806603
- 3014211783
- 3006550224
- 3003898360
- 2025870
- 3016678045
- 2124215
- 3009766315
- 3009380063
- 3010665433
- 3010432890
- 2024168
- 3038912532
- 3013944123
- 3015309643
- 2011171
- 3014779787
- 3030733800
- 2183744
- 3005012805
- 1000121056
- 3008361782
- 2184009
- 3000247873
- 3013557562
- 2939561
- 3016444913
- 2020394
- 3014498720
- 2528981
- 8043892
- 2024024
- 1018233
- 3032047719
- 3014644549
- 8023054
- 3010041511
- 3006451981
- 2182208
- 3014656749
- 1064858
- 3035111606
- 3015225571
- 3027343398
- 3010079067
- 2523676
- 3011706110
- 9710641
- 3016948450
- 9612164
- 3005255160
- 2135147
- 2029214
- 3007113487
- 3015859709
- 3016171942
- 3004091615
- 3008700817
- 1318694
- 1928237
- 2649622
- 2017865
- 1123137
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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
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