510(k) K981203 ยท KNT Tubes, Gastrointestinal (And Accessories)
RUSCH BLAKEMORE 3 LUMEN, STERILE
| Applicant | Rusch Intl., Jeffrey NH, US |
| Decision | Substantially Equivalent, Jun 5, 1998 |
| Received | Apr 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2014 | Teleflex Medical Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instil Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.