510(k) K052395 ยท KKX Drape, Surgical, Antimicrobial
STERILE EQUIPMENT COVERS
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Dec 1, 2005 |
| Received | Aug 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2016 | Volcano Corporation Volcano R100 Sterile Equipment Cover; Sterile;
General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be ste Terminated |
KKX | None listed |
| Mar 3, 2016 | Volcano Corporation Volcano SpinVision Sterile Equip cover II; Sterile;
General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot b Terminated |
KKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.