Target Detachable Coils— 510(k) K153658

Clearance details

Applicant

Stryker Neurovascular

Product code

Code HCG

Device class

Class 2

Regulation

21 CFR 882.5950

Advisory panel

Neurology

Date received

2015-12-21

Decision date

2016-05-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fremont, CA, US

• K262419 — MICRUSFRAME (19+ models)2026-08-14
• K261772 — Target Xtra Detachable Coil2026-06-24
• K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
• K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
• K252694 — Target Detachable Coil2025-12-11

• K261889 — Trevo Trak 21 Microcatheter2026-07-01
• K253032 — AXS Lift Intracranial Base Catheter2026-02-11
• K251832 — InZone IST Detachment System; IZDS Connecting Cable2025-10-17
• K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter2025-03-21
• K243593 — AXS Lift Intracranial Base Catheter2025-02-18

Death

50

Injury

801

Malfunction

5,625

Total

6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2160-2016 — Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2161-2016 — Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2162-2016 — Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2163-2016 — Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2164-2016 — Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2165-2016 — Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2166-2016 — Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2167-2016 — Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2168-2016 — Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2169-2016 — Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2170-2016 — Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2171-2016 — Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2172-2016 — Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2173-2016 — Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2174-2016 — Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2175-2016 — Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2176-2016 — Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2177-2016 — Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2178-2016 — Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606
• Z-2179-2016 — Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.Class II·Terminated·Stryker Neurovascular·20160606

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153658.