The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models.
| Device ID | K033372 |
| 510k Number | K033372 |
| Device Name: | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Florin Truuvert |
| Correspondent | Florin Truuvert MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2004-01-09 |
| Summary: | summary |