510(k) K896729 ยท KOD Catheter, Urological
NELATON-, FEMALE - OR TIEMANN CATHETER
| Applicant | Unoplast A/S, Denmark, DK |
| Decision | Substantially Equivalent, Nov 5, 1990 |
| Received | Nov 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2019 | ConvaTec, Inc Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM
Product Usage:
Urinary Catheters are sterile disposable devices intended to provide an in Open, Classified |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 16 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 16 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | None listed |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.