← Product Code [FFA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFA) · K944290

# CATHETERS, BILIARY CATHETERS, UROLOGICAL (K944290)

_Boston Scientific Corp · FFA · Dec 8, 1994 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFA/K944290

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** [FFA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFA.md)
- **Decision Date:** Dec 8, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5090
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFA/K944290](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFA/K944290)

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