510(k) K962472 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
| Applicant | Rusch Intl., Jeffrey NH, US |
| Decision | Substantially Equivalent, Aug 27, 1996 |
| Received | Jun 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2018 | Teleflex Medical Europe Ltd Rectal Catheters;
Product Code Equivalent Code
580114 580114
Product Usage:
Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled. Terminated |
FAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.