FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL— 510(k) K993418

Name: FDA 510(k) clearance K993418
Creator: U.S. Food and Drug Administration
Published: 2000-01-21

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K993418 for FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL, Substantially Equivalent on 2000-01-21. Applicant: Boston Scientific, Target. Device class: 2.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 1999-10-01
Decision date: 2000-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
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K252694 — Target Detachable Coil2025-12-11

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K030475 — GDC STRETCH RESISTANT DETACHABLE COIL2003-03-14
K022860 — ATLANTIS PV IMAGING CATHETER, MODEL 364562002-11-21
K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-8152002-10-16

Adverse events under product code HCG

product code HCG

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 →

Recalls naming K993418

K-number listed on FDA's recall record

Z-0504-2014 — Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.Class II·Terminated·Stryker Neurovascular·20131104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993418.

Data sourced from openFDA. This site is unofficial and independent of the FDA.