Atlas FDA

Target Detachable Coils

FDA 510(k) clearance K153658 · decided 2016-05-19

Clearance details

K-number
K153658
Device name
Target Detachable Coils
Applicant
Stryker Neurovascular
Decision
Substantially Equivalent
Date received
2015-12-21
Decision date
2016-05-19
Days to decision
150 days
Clearance type
Traditional
Product code
HCG
Device class
2
Regulation number
882.5950
Medical specialty
Neurology
Advisory committee
Neurology
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Target Xtra Detachable Coil (K261772)Stryker Neurovscular2026-06-24
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Recalls involving this device

RecordFirmDate
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: recall (Z-2160-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: recall (Z-2161-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology recall (Z-2162-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology recall (Z-2163-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: recall (Z-2164-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurolog recall (Z-2165-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurolog recall (Z-2166-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurolog recall (Z-2167-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurol recall (Z-2168-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurol recall (Z-2169-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurol recall (Z-2170-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurol recall (Z-2171-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Tar recall (Z-2172-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Tar recall (Z-2173-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: recall (Z-2174-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Tar recall (Z-2175-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Tar recall (Z-2176-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: recall (Z-2177-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: recall (Z-2178-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: recall (Z-2179-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: recall (Z-2180-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: recall (Z-2181-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurolog recall (Z-2182-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurolog recall (Z-2183-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: recall (Z-2184-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: recall (Z-2185-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: recall (Z-2186-2016)Stryker Neurovascular2016-07-11
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: recall (Z-2187-2016)Stryker Neurovascular2016-07-11

PMA approvals by this applicant

RecordFirmDate
Surpass Streamline Flow Diverter (P170024/S024)Stryker Neurovascular2025-08-20
Neuroform Atlas® Stent System (P180031/S006)Stryker Neurovascular2025-06-24
Surpass Streamline Flow Diverter (P170024/S023)Stryker Neurovascular2025-05-30
Neuroform Atlas Stent System (P180031/S011)Stryker Neurovascular2025-05-09
Surpass Elite Flow Diverter System (P170024/S022)Stryker Neurovascular2025-02-12
Neuroform Atlas Stent System (P180031/S010)Stryker Neurovascular2024-12-09
Neuroform Atlas Stent System (P180031/S009)Stryker Neurovascular2024-11-18
Surpass Elite Flow Diverter System (P170024/S018)Stryker Neurovascular2024-10-16