ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
Device Facts
| Record ID | K873688 |
|---|---|
| Device Name | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL |
| Applicant | Dentsply Intl. |
| Product Code | JXH · Neurology |
| Decision Date | Oct 26, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5030 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.
