510(k) K933400 ยท KOD Catheter, Urological
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
| Applicant | Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA, US |
| Decision | Substantially Equivalent, Nov 15, 1993 |
| Received | Jul 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Foley Catheter with Temperature Sensor
14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescriptio Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Secu Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Sec Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, T Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: Terminated |
KOD | None listed |
| Apr 30, 2020 | Covidien Llc Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS Terminated |
KOD | None listed |
| Jul 11, 2018 | COVIDIEN LLC P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.