KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
FDA 510(k) clearance K933400 · decided 1993-11-15
Clearance details
- K-number
- K933400
- Device name
- KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Decision
- Substantially Equivalent
- Date received
- 1993-07-12
- Decision date
- 1993-11-15
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|
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| UroGen Ureteral Catheter (K180354) | Urogen Pharma, Ltd. | 2018-10-30 |
| Angled Tip Ureteral Catheter (K181144) | Cook Incorporated | 2018-06-28 |
| Imager II Urology Torque Catheter (K180530) | Boston Scientific Corporation | 2018-04-10 |
| Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810) | Cook Incorporated | 2018-03-07 |
| Renal Access Cobra Catheter, Kumpe Access Catheter (K171600) | Cook Incorporated | 2018-02-16 |
| Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662) | Cook Incorporated | 2018-02-01 |
| GentleCath Intermittent Urinary Catheter (K172924) | Convatec Limited | 2017-11-21 |
Recalls involving this device
No recalls on record reference this clearance.