TRAY, CATHETERIZATION W/ CATHETER
Device Facts
| Record ID | K760128 |
|---|---|
| Device Name | TRAY, CATHETERIZATION W/ CATHETER |
| Applicant | Concord Laboratories, Inc. |
| Product Code | FCM · Gastroenterology, Urology |
| Decision Date | Oct 7, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
