Target Detachable Coil— 510(k) K252694
Substantially EquivalentStryker Neurovascular
FDA 510(k) clearance K252694 for Target Detachable Coil, Substantially Equivalent on 2025-12-11. Applicant: Stryker Neurovascular. Device class: 2.
Clearance details
- Applicant
- Stryker Neurovascular
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code HCG
view allMore clearances from Stryker Neurovascular
view all- K261889 — Trevo Trak 21 Microcatheter
- K253032 — AXS Lift Intracranial Base Catheter
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
- K243593 — AXS Lift Intracranial Base Catheter
- K241637 — Echo Intracranial Base Catheter
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.