The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Nexus Detachable Coil System, Morpheus 3d Csr.
| Device ID | K060625 |
| 510k Number | K060625 |
| Device Name: | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-09 |
| Decision Date | 2006-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462019812 | K060625 | 000 |
| 00836462019669 | K060625 | 000 |
| 00836462019676 | K060625 | 000 |
| 00836462019683 | K060625 | 000 |
| 00836462019690 | K060625 | 000 |
| 00836462019706 | K060625 | 000 |
| 00836462019713 | K060625 | 000 |
| 00836462019720 | K060625 | 000 |
| 00836462019737 | K060625 | 000 |
| 00836462019744 | K060625 | 000 |
| 00836462019751 | K060625 | 000 |
| 00836462019768 | K060625 | 000 |
| 00836462019775 | K060625 | 000 |
| 00836462019782 | K060625 | 000 |
| 00836462019799 | K060625 | 000 |
| 00836462019805 | K060625 | 000 |
| 00836462019652 | K060625 | 000 |