2 results
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9ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459258(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459265(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·April 8, 2020
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459227(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459234(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·April 8, 2020