The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Bare Platinum Framing Coil, Model(s) 100408bpfc-v,100412bpfc-v,100515bpfc-v100518bpfc-v,100522bpfc-v,100618bpfc-v100622b.
| Device ID | K082461 |
| 510k Number | K082461 |
| Device Name: | BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B |
| 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 | 2008-08-27 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170013539 | K082461 | 000 |