FIBERED PLATINUM COIL, .035 TYPE
Device Facts
| Record ID | K955293 |
|---|---|
| Device Name | FIBERED PLATINUM COIL, .035 TYPE |
| Applicant | Target Therapeutics |
| Product Code | KRD · Cardiovascular |
| Decision Date | Feb 6, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
