CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
Device Facts
| Record ID | K813084 |
|---|---|
| Device Name | CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET |
| Applicant | Burron Medical Products, Inc. |
| Product Code | KOB · Gastroenterology, Urology |
| Decision Date | Dec 31, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5090 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
