510(k) K181735 ยท LJE Catheter, Nephrostomy
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Unknown, Mar 27, 2019 |
| Received | Jul 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | Cook Inc. Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) Terminated |
LJE | None listed |
| Aug 31, 2020 | Cook Inc. Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull ti Terminated |
LJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.