K915495 is an FDA 510(k) clearance for the DESERET POSITIONAL SUTURE WING. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 6, 1992, 119 days after receiving the submission on December 9, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K915495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1991 |
| Decision Date | April 06, 1992 |
| Days to Decision | 119 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 |