K052395 is an FDA 510(k) clearance for the STERILE EQUIPMENT COVERS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on December 1, 2005, 92 days after receiving the submission on August 31, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K052395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2005 |
| Decision Date | December 01, 2005 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |