Neurovascular Access System Family
Q'Apel Medical, Inc.
Q'apel Medical, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3020954126 | 3020954126 | Q'apel Medical, Inc. | 1 | N | 2026-01-01 | 4245 Technology Drive Fremont CA US 94538 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 298797 | 1613905267 | K254276 | Lynx Aspiration Catheter System | NRY | 2026-05-07 |
| 298797 | 1524621124 | K240746 | Neurovascular Access System Family | QJP | 2024-11-20 |
| 298797 | 1060004485 | K211893 | SelectFlex Neurovascular Access System Family | QJP | 2021-08-05 |
| 298797 | 1098181686 | K192525 | 087 Balloon Guide Catheter System | DQY | 2019-10-31 |
| 298797 | 1365766177 | K190749 | 087 Balloon Guide Catheter System | DQY | 2019-07-15 |
Product Codes Associated With Registrations#
PMN#
072 Aspiration System
Q'Apel Medical, Inc.
SelectFlex Neurovascular Access System Family
Q'Apel Medical, Inc.
SelectFlex Neurovascular Access System Family
Q'Apel Medical Inc
087 Balloon Guide Catheter System
Q'Apel Medical LLC
SelectFlex 072 Neurovascular Access System
Q'Apel Medical
GUDID#
Lynx Aspiration Catheter System - Lynx Aspiration Catheter System 072, 132cm
2026-05-29
Lynx Aspiration Catheter System - Lynx Aspiration Catheter System 058, 138cm
2026-05-29
Lynx Aspiration Catheter System - Lynx Aspiration Catheter System 058, 149cm
2026-05-29
Lynx Aspiration Catheter System - Lynx Aspiration Catheter System 044, 145cm
2026-05-29
Lynx Aspiration Catheter System - Lynx Aspiration Catheter System 044, 160cm
2026-05-29
Walrus - 087 Balloon Guide Catheter System, 90cm
2021-06-29
Walrus - 087 Balloon Guide Catheter System, 95cm
2021-06-29
6F Armadillo - SelectFlex III 064 Neurovascular Access System 105 cm, 30 cm Variable Stiffness, 30cm Coating.
2023-08-04
Wahoo - SelectFlex 072 Neurovascular Access System, 105cm
2021-06-29
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
2026-03-05
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
2026-03-05
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
2026-03-05
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
2026-03-05
072 Aspiration System - As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
2023-10-11
072 Aspiration System - 072 Aspiration Tubing
2023-10-11
072 Aspiration System - 072 Aspiration Kit (REF: APT6072-132) = 072 Aspiration System + 072 Aspiration Tubing
2023-10-11
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Zebra - The Neurovascular Access System Family consists of sterile, single-use catheters andaccessories that are used together to facilitate the insertion and guidance of an appropriately sizedinterventional device into a selected vessel in the peripheral and neurovasculature. TheNeurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, PeelAway Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths toaccommodate physician preferences and anatomical variations. The distal end of the catheter iscoated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distaltip that is visible under fluoroscopy.
2025-01-03
Armadillo - SelectFlex II 072 Neurovascular Access System 105cm, 22cm Variable Stiffness, 30cm Coating
2022-01-16
Armadillo - SelectFlex II 072 Neurovascular Access System 95cm, 22cm Variable Stiffness, 30cm Coating
2022-01-16
Armadillo - SelectFlex II 072 Neurovascular Access System 95cm, 27cm Variable Stiffness, 30cm Coating
2022-01-16
Armadillo - SelectFlex II 072 Neurovascular Access System 105cm, 27cm Variable Stiffness, 30cm Coating
2022-01-16