510(k) K030004 ยท MED Sterilant, Medical Devices
0.55% ORTH-PHTHALALDEHYDE SOLUTION
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Feb 27, 2003 |
| Received | Jan 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2015 | Advanced Sterilization Products CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. Terminated |
MED | None listed |
| Aug 27, 2012 | Advanced Sterilization Products CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. Terminated |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.