inarimedical.comIntri26 Introducer Sheath
Inari Medical, Inc.
Inari Medical, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3020347218 | 3020347218 | Inari Medical, Inc. | 1 | N | 2026-01-01 | 6001 Oak Canyon, Suite 100 Irvine CA US 92618 |
| 3040801290 | 3040801290 | Inari Medical, Costa Rica S.A. | 1 | N | 2026-01-01 | Evolution Free Zone, Building 02 Tacares Grecia Alajuela CR 20305 |
| 3011525976 | 3011525976 | INARI MEDICAL | 1 | N | 2020-04-25 | 9 Parker Suite 100 Irvine CA US 92618 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810123710065 | Triever20 - 21-101 | 18779234747 | info@inarimedical.com |
| 00810123710096 | Triever24 - 22-101 | 18779234747 | info@inarimedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 337928 | 1807967626 | K253323 | Protrieve Sheath | QEW | 2025-10-29 |
| 337928 | 1512666187 | K250421 | InThrill™ Thrombectomy System | QEW | 2025-05-12 |
| 337928 | 1958266195 | K250088 | FlowTriever2 Catheter | QEW | 2025-03-13 |
| 337928 | 1900616310 | K242557 | ClotTriever XL Catheter (41-102) | QEW | 2024-09-27 |
| 337928 | 1873612954 | K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | QEW | 2024-10-15 |
| 337928 | 1988221296 | K234034 | VenaCore Thrombectomy Catheter (46-101) | QEW | 2024-02-09 |
| 337928 | 1643258312 | K233815 | ClotTriever Sheath | QEW | 2023-12-18 |
| 337928 | 1181507225 | K233646 | Intri24 Introducer Sheath (52-101) | DYB | 2023-12-12 |
| 337928 | 1733796687 | K231848 | Triever20 Curve (21-201) | QEW | 2023-07-21 |
| 337928 | 1447648364 | K231782 | FlowSaver Blood Return System (80-101) | CAC | 2023-07-14 |
| 337928 | 1654186959 | K231108 | Talon Transseptal Sheath | DYB | 2023-09-27 |
| 337928 | 1825880829 | K230912 | Artix BG | QEW | 2023-05-02 |
| 337928 | 1038628108 | K230494 | ClotTriever BOLD Catheter | QEW | 2023-04-18 |
| 337928 | 1244044112 | K223609 | RevCore™ Thrombectomy Catheter. | QEW | 2023-03-14 |
| 337928 | 2003565752 | K223436 | Artix AX | QEW | 2023-03-02 |
| 337928 | 1435948722 | K223419 | Triever16 Curve | QEW | 2023-03-23 |
| 337928 | 1485417971 | K221531 | ClotTriever Thrombectomy System | QEW | 2023-02-06 |
| 337928 | 1134741280 | K221483 | FlowSaver Blood Return System | CAC | 2023-02-17 |
| 347890 | 1057913002 | K213402 | Triever24, Triever20 | QEW | 2022-05-23 |
| 337928 | 1057913002 | K213402 | Triever24, Triever20 | QEW | 2022-05-23 |
| 337928 | 1159845169 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 | QEW | 2021-04-30 |
| 337928 | 1813503206 | K210689 | ClotTriever Thrombectomy System | QEW | 2021-05-12 |
| 337928 | 1643382737 | K210190 | ClotTriever Thrombectomy System | QEW | 2021-02-23 |
| 233610 | 1511339391 | K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath | QEW | 2019-09-20 |
| 233610 | 1381509910 | K191710 | FlowTriever Retrieval/Aspiration System | QEW | 2019-09-05 |
| 337928 | 1786210648 |
Product Codes Associated With Registrations#
PMN#
InThrill? Thrombectomy System
Inari Medical, Inc.
Artix? MT; Artix? Thin-Walled Thrombectomy Sheath
Inari Medical, Inc.
ClotTriever XL Catheter (41-102)
Inari Medical, Inc.
Removal System Large Bore 60 cc Syringe
Inari Medical, Inc.
VenaCore Thrombectomy Catheter (46-101)
Inari Medical, Inc.
ClotTriever Sheath
Inari Medical, Inc.
Intri24 Introducer Sheath (52-101)
Inari Medical, Inc.
Talon Transseptal Sheath
Inari Medical, Inc.
Triever20 Curve (21-201)
Inari Medical, Inc.
FlowSaver Blood Return System (80-101)
Inari Medical, Inc.
Artix BG
Inari Medical
ClotTriever XL Catheter
Inari Medical, Inc.
ClotTriever BOLD Catheter
Inari Medical, Inc.
Triever16 Curve
Inari Medical
InThrill Thrombectomy System
Inari Medical, Inc.
RevCore? Thrombectomy Catheter.
Inari Medical, Inc.
Protrieve Sheath
Inari Medical, Inc.
Artix AX
Inari Medical
FlowSaver Blood Return System
Inari Medical, Inc.
ClotTriever Thrombectomy System
Inari Medical, Inc.
Artix BG
Inari Medical
Mini-ClotTriever Thrombectomy System
Inari Medical
Protrieve Sheath
Inari Medical, Inc.
Artix Ballon Guiding Sheath
Inari Medical
Triever24, Triever20
Inari Medical
Intri24 Sheath
Inari Medical, Inc.
Artix Thrombectomy Device
Inari Medical
ClotTriever Thrombectomy System
Inari Medical, Inc.
FlowSaver Blood Filter
Inari Medical
ClotTriever Thrombectomy System
Inari Medical, Inc.
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
Inari Medical, Inc.
Triever Catheters
Inari Medical
FlowTriever Retrieval/Aspiration System
Inari Medical
Triever20 Curve Catheter
Inari Medical, Inc.
FlowTriever Retrieval/Aspiration System
Inari Medical
ClotTriever Thrombectomy System
Inari Medical
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
Inari Medical
FlowTriever Retrieval/Aspiration System
Inari Medical
ClotTriever Thrombectomy System
Inari Medical
GUDID#
VenaCore Thrombectomy Catheter - AS-01160
2024-03-27
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
FlowSaver - AS-01189/ 80-101
2024-05-29
LimFlow ARC - The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature
2024-04-19
Triever24 - 22-101
2024-04-17
ClotTriever Catheter - ClotTriever, 16mm
2024-04-17
Triever20 - 21-101
2024-04-16
Triever LA Transseptal Sheath - 121-101/ AS-01084
2024-04-15
LimFlow Vector - The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
2024-04-12
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
LimFlow V-Ceiver - The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
2024-03-09
ClotTriever Sheath, 13 Fr - ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System)
2023-12-15
ClotTriever Sheath, 16 Fr - ClotTriever Sheath, 16 Fr (ClotTriever Thrombectomy System)
2023-12-15
Triever20 Curve - 21-201/ AS-01159
2023-12-15
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
LimFlow System - LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
LimFlow System - LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
LimFlow System - LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
Artix Thin-Walled Sheath - 30-104 / AS-01206
2024-11-11
Artix AX - Artix AX, 85cm
2026-01-06
Artix AX - Artix AX, 115cm
2026-01-06
Intri26 Introducer Sheath - 52-102
2026-01-06
InThrill Thrombectomy Catheter - InThrill Thrombectomy Catheter (AS-01312)
2025-05-30
InThrill Sheath - InThrill Sheath (AS-01403)
2025-05-30
FlowTriever2 Catheter - FlowTriever2 Catheter (AS-01397)
2025-05-28
ClotTriever BOLD Catheter - 42-102
2025-04-09
InThrill Thrombectomy Catheter - 43-102
2024-12-20
Large Bore 60 cc Syringe - 99-102
2024-12-20
LimFlow System - LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2023-10-02
Artix MT - Artix MT (Thrombectomy Device)
2024-11-11
Artix MT - Artix MT (Thrombectomy Device)
2024-11-11
Artix Thin-Walled Sheath - Artix Thin-Walled Sheath (Thrombectomy Sheath)
2024-11-07
16 Fr Evacuation System - 131-101 / AS-01226
2024-10-10
24 Fr Evacuation System - 131-102 / AS-01229
2024-10-10
LimFlow Crossing Stent Graft - LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
LimFlow Crossing Stent Graft - LimFlow Crossing Stent Graft (4.0-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
LimFlow Extension Stent Graft - LimFlow Extension Stent Graft (5.5 mm x 60 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
2024-10-08
FlowTriever - Retraction Aspirator
2016-09-15