510(k) K150927 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, May 27, 2015 |
| Received | Apr 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150927
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.