510(k) K242756 ยท DYB Introducer, Catheter
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
| Applicant | Pulnovo Medical (Wuxi) Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Nov 8, 2024 |
| Received | Sep 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242756
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.