The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Confida Adaptive Sheath.
| Device ID | K152054 |
| 510k Number | K152054 |
| Device Name: | Confida Adaptive Sheath |
| Classification | Introducer, Catheter |
| Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 |
| Contact | Matthew Lobeck |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-07-23 |
| Decision Date | 2015-08-07 |
| Summary: | summary |