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510(k) Data Aggregation
K Number
K242243Device Name
Target Detachable Coils
Manufacturer
Stryker Neurovscular
Date Cleared
2024-08-29
(29 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
Stryker Neurovscular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils are indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
Device Description
Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra. All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless-steel delivery wire.
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