GDC STRETCH RESISTANT DETACHABLE COIL— 510(k) K030475

Clearance details

Applicant

Boston Scientific, Target

Product code

Code HCG

Device class

Class 2

Regulation

21 CFR 882.5950

Advisory panel

Neurology

Date received

2003-02-13

Decision date

2003-03-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Fremont, CA, US

• K262419 — MICRUSFRAME (19+ models)2026-08-14
• K261772 — Target Xtra Detachable Coil2026-06-24
• K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
• K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
• K252694 — Target Detachable Coil2025-12-11

• K031049 — GUGLIELMI DETACHABLE COIL (GDC)2003-08-01
• K031168 — MATRIX STRETCH RESISTANT DETACHABLE COIL2003-05-14
• 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
• K021494 — GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-42002-06-06

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 →

• Z-0502-2014 — Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; 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 K030475.