The following data is part of a premarket notification filed by Mivi, Llc with the FDA for Mivi 6f Guide Catheter.
| Device ID | K140557 |
| 510k Number | K140557 |
| Device Name: | MIVI 6F GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MIVI, LLC 10900 73RD AVE NE, SUITE 150 Maple Grove, MN 55369 |
| Contact | Michelle Straight |
| Correspondent | Michelle Straight MIVI, LLC 10900 73RD AVE NE, SUITE 150 Maple Grove, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B293MIA571300 | K140557 | 000 |
| B293MIA571120 | K140557 | 000 |