The following data is part of a premarket notification filed by Interrad Medical Inc with the FDA for Securacath 10f, Securacath 12f, Securacath 5f, Securacath 5f, Securacath 6f, Securacath 7f/securacath 8f.
| Device ID | K180994 |
| 510k Number | K180994 |
| Device Name: | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | Interrad Medical Inc 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Contact | Denise Lenz |
| Correspondent | Denise Lenz Libra Medical, Inc 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2019-07-09 |