510(k) K052134 ยท KNY Accessories, Catheter, G-U
CYSTOGLIDE DILATING INTRODUCER SHEATH
| Applicant | Percutaneous Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 22, 2005 |
| Received | Aug 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052134
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.