K180994 is an FDA 510(k) clearance for the SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Interrad Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 9, 2019, 449 days after receiving the submission on April 16, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K180994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | July 09, 2019 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMK — Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |