K943047 is an FDA 510(k) clearance for the IV START KITS. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on September 14, 1994, 79 days after receiving the submission on June 27, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K943047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1994 |
| Decision Date | September 14, 1994 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KMK — Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |