K912211 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER SECURMENT DEVICE. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Inman Liebelt Corp. (Arlington, US). The FDA issued a Cleared decision on August 9, 1991, 81 days after receiving the submission on May 20, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K912211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1991 |
| Decision Date | August 09, 1991 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KMK — Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |