The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Nexus Detachable Coil System, Helix Super Soft Csr.
| Device ID | K051425 |
| 510k Number | K051425 |
| Device Name: | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT 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 | 2005-06-01 |
| Decision Date | 2005-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462019645 | K051425 | 000 |
| 00836462019539 | K051425 | 000 |
| 00836462019522 | K051425 | 000 |
| 00836462019515 | K051425 | 000 |
| 00836462019508 | K051425 | 000 |
| 00836462019492 | K051425 | 000 |
| 00836462019485 | K051425 | 000 |
| 00836462019478 | K051425 | 000 |
| 00836462019461 | K051425 | 000 |
| 00836462019546 | K051425 | 000 |
| 00836462019553 | K051425 | 000 |
| 00836462019638 | K051425 | 000 |
| 00836462019621 | K051425 | 000 |
| 00836462019614 | K051425 | 000 |
| 00836462019607 | K051425 | 000 |
| 00836462019591 | K051425 | 000 |
| 00836462019584 | K051425 | 000 |
| 00836462019577 | K051425 | 000 |
| 00836462019560 | K051425 | 000 |
| 00836462019454 | K051425 | 000 |