The following data is part of a premarket notification filed by Intravu, Inc. with the FDA for Midascope And Introducer Kit, And Midasystem.
| Device ID | K181982 |
| 510k Number | K181982 |
| Device Name: | MIDAScope And Introducer Kit, And MIDASystem |
| Classification | Arthroscope |
| Applicant | IntraVu, Inc. 610 Price Avenue Redwood City, CA 94063 |
| Contact | Plamena Entcheva-dimitrov |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2018-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865351000334 | K181982 | 000 |
| 00850023905048 | K181982 | 000 |
| 00850023905055 | K181982 | 000 |
| 00850023905000 | K181982 | 000 |
| 00850023905017 | K181982 | 000 |
| 00850023905024 | K181982 | 000 |
| 00865351000389 | K181982 | 000 |
| 00865351000341 | K181982 | 000 |
| 00865351000358 | K181982 | 000 |
| 00865351000365 | K181982 | 000 |
| 00865351000372 | K181982 | 000 |
| 00865351000303 | K181982 | 000 |
| 00865351000310 | K181982 | 000 |
| 00865351000327 | K181982 | 000 |
| 00850023905031 | K181982 | 000 |