Target Detachable Coil
by Stryker Neurovascular 4 variants
510(k) K252694
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252694 | Date11 Dec 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HCG
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5950
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Target Detachable Coil is a neurovascular embolization device designed for cerebral aneurysm occlusion. It is a detachable coil used in endovascular procedures to permanently occlude blood vessels, preventing blood flow into aneurysms and reducing the risk of rupture.
This device is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulations (882.5950) and has received FDA 510(k) clearance (K252694) as substantially equivalent to a predicate device. The coil is delivered via microcatheters and deployed within the aneurysm sac to achieve embolization, with multiple coil sizes available for various clinical applications.
From the manufacturer
For over 10 years, we have been continuously making Target Coils better. With Target Tetra, we've combined a stable, tetrahedral shape with incredible softness, making it an excellent option for treating small spaces from frame to finish. Target Tetra is our softest coil, yet has enhanced shape stability, so you're never compromising one advantage for the other.
Target 3D Detachable Coil | Stryker. Target Tetra Detachable Coil For over 10 years, we have been continuously making Target Coils better. With Target Tetra, we've combined a stable, tetrahedral shape with incredible softness, making it an excellent option for treating small spaces from frame to finish.