The following data is part of a premarket notification filed by Mc3 Incorporated with the FDA for Mc3 Vascular Access Kit 21030.
| Device ID | K182914 |
| 510k Number | K182914 |
| Device Name: | MC3 Vascular Access Kit 21030 |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MC3 Incorporated 2555 Bishop Circle West Dexter, MI 48130 |
| Contact | Adam Viitala |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-10-18 |
| Decision Date | 2018-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854916006833 | K182914 | 000 |