The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415.
| Device ID | K090168 |
| 510k Number | K090168 |
| Device Name: | AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Contact | Florin Truuvert |
| Correspondent | Florin Truuvert MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170018084 | K090168 | 000 |
| 00810170013850 | K090168 | 000 |
| 00810170013843 | K090168 | 000 |
| 00810170013836 | K090168 | 000 |
| 00810170013829 | K090168 | 000 |
| 00810170013812 | K090168 | 000 |
| 00810170013805 | K090168 | 000 |
| 00810170013799 | K090168 | 000 |
| 00810170013782 | K090168 | 000 |
| 00810170013775 | K090168 | 000 |
| 00810170013867 | K090168 | 000 |
| 00810170017872 | K090168 | 000 |
| 00810170018060 | K090168 | 000 |
| 00810170018039 | K090168 | 000 |
| 00810170018022 | K090168 | 000 |
| 00810170017957 | K090168 | 000 |
| 00810170017940 | K090168 | 000 |
| 00810170017926 | K090168 | 000 |
| 00810170017919 | K090168 | 000 |
| 00810170017896 | K090168 | 000 |
| 00810170017889 | K090168 | 000 |
| 00810170013768 | K090168 | 000 |