510(k) K153688 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Edi Catheter ENFit
| Applicant | Maquet Critical Care AB, Solna, SE |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Dec 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2019 | GETINGE US SALES LLC Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
Product Code/REF Number: 6685775
Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode ar Terminated |
PIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.