POWERLINK WITH INTUITRAK DELIVERY SYSTEM
ENDOLOGIX, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008011247 | 3008011247 | Endologix LLC | 1 | N | 2026-01-01 | 3910 Brickway Blvd Santa Rosa CA US 95403 |
| 3011063223 | 3011063223 | Endologix LLC | 1 | N | 2026-01-01 | 35 Hammond Irvine CA US 92618 |
| 3015365904 | 3015365904 | Endologix LLC | 1 | N | 2026-01-01 | 1971 Milmont Dr Milpitas CA US 95035 |
| 3013162347 | 3013162347 | Endologix International Holdings B.V. | 1 | N | 2020-04-25 | Europalaan 30 Hertogenbosch Noord-Brabant NL 5232 BC's |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850007370329 | Ovation iX Iliac Stent Graft - The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated. | (949) 595-7200 | CustomerService@endologix.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 224236 | 1993117952 | P220021 | DETOUR System | QWM | 2023-06-07 |
| 318465 | 1993117952 | P220021 | DETOUR System | QWM | 2023-06-07 |
| 224236 | 1962862557 | P120006 | OVATION ABDOMINAL STENT GRAFT SYSTEM | MIH | 2012-10-05 |
| 175360 | 1433534800 | P040002 | ENDOLOGIX POWERLINK SYSTEM | MIH | 2004-10-29 |
| 197380 | 1433534800 | P040002 | ENDOLOGIX POWERLINK SYSTEM | MIH | 2004-10-29 |
| 175360 | 1301735027 | K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | DQY | 1999-10-28 |
| 197380 | 1301735027 | K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | DQY | 1999-10-28 |
| 175360 | 1587415105 | K120212 | AFX INTRODUCER SYSTEM | DYB | 2012-02-09 |
| 197380 | 1587415105 | K120212 | AFX INTRODUCER SYSTEM | DYB | 2012-02-09 |
| 224236 | 1097912016 | H100008 |
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
ENDOLOGIX, INC.
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