The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Nexus Detachable Coil System.
| Device ID | K050543 |
| 510k Number | K050543 |
| Device Name: | NEXUS DETACHABLE COIL SYSTEM |
| 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 | 2005-03-02 |
| Decision Date | 2005-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462019386 | K050543 | 000 |
| 00836462019287 | K050543 | 000 |
| 00836462019294 | K050543 | 000 |
| 00836462019300 | K050543 | 000 |
| 00836462019317 | K050543 | 000 |
| 00836462019324 | K050543 | 000 |
| 00836462019331 | K050543 | 000 |
| 00836462019348 | K050543 | 000 |
| 00836462019355 | K050543 | 000 |
| 00836462019362 | K050543 | 000 |
| 00836462019379 | K050543 | 000 |
| 00836462019270 | K050543 | 000 |