The following data is part of a premarket notification filed by Libra Medical Inc. with the FDA for Flexseal Introducer Sheath With Hydrophilic Coating.
| Device ID | K161659 |
| 510k Number | K161659 |
| Device Name: | FlexSeal Introducer Sheath With Hydrophilic Coating |
| Classification | Introducer, Catheter |
| Applicant | LIBRA MEDICAL INC. 8401 73RD AVE NORTH SUITE 63 Minneapolis, MN 55428 |
| Contact | Sew-wah Tay |
| 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 | 2016-06-16 |
| Decision Date | 2016-07-15 |
| Summary: | summary |