K993417 is an FDA 510(k) clearance for the GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC). This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on January 21, 2000, 112 days after receiving the submission on October 1, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K993417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1999 |
| Decision Date | January 21, 2000 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |