GUGLIELMI DETACHABLE COIL (GDC)— 510(k) K031049
Substantially EquivalentBoston Scientific, Target
FDA 510(k) clearance K031049 for GUGLIELMI DETACHABLE COIL (GDC), Substantially Equivalent on 2003-08-01. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code HCG
view allMore clearances from Boston Scientific, Target
view all- K031168 — MATRIX STRETCH RESISTANT DETACHABLE COIL
- K030475 — GDC STRETCH RESISTANT DETACHABLE COIL
- K022860 — ATLANTIS PV IMAGING CATHETER, MODEL 36456
- K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
- K021494 — GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
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.