← Product Code [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE) · K954713

# DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) (K954713)

_Ideas For Medicine, Inc. · FGE · Jul 24, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K954713

## Device Facts

- **Applicant:** Ideas For Medicine, Inc.
- **Product Code:** [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE.md)
- **Decision Date:** Jul 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5010
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.

## Device Story

Radiopaque multi-lumen balloon catheter; includes ancillary lumens for injection/irrigation and separate lumen for balloon inflation. Used by physicians during biliary procedures to remove stones/debris and explore biliary tree. Irrigation capabilities facilitate lubrication, flushing, and cholangiography. Device functions via mechanical balloon inflation and fluid delivery through lumens.

## Clinical Evidence

Bench testing only; biocompatibility testing performed on all materials.

## Technological Characteristics

Radiopaque multi-lumen balloon catheter. Materials identical to manufacturer's previously cleared cardiovascular/laparoscopic devices. Biocompatibility testing completed.

## Regulatory Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Predicate Devices

- Fogarty Biliary Balloon Probe
- Edslab Irrigation Catheter
- Ideas for Medicine Trilumen Intravascular Catheter for Gu Use
- Bard Stone Removal Balloon Catheters

## Reference Devices

- Pruitt Irrigation-Embolectomy catheters
- Pruitt Irrigation Occlusion Catheters
- Robiscek Angiography-Embolectomy Catheters
- Reddick Cystic Duct Catheters
- Grice Laparoscopic Sump

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K954713

Ideas for Medicine, Inc. 510(k) 954713

# SAFETY AND EFFECTIVENESS SUMMARY

**PROPRIETARY NAME**

Pruitt Biliary Catheter

**COMMON/USUAL NAME**

Biliary Catheter

**CLASSIFICATION:** 21 CFR 876.5010

**JUL 24 1996**

## DEVICE DESCRIPTION

The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation; another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.

## INTENDED USE

The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.

## SUBSTANTIAL EQUIVALENCE

The materials used to manufacture these devices are identical to the materials used to manufacture the Pruitt Irrigation-Embolectomy catheters, Pruitt Irrigation Occlusion Catheters, Robiscek Angiography-Embolectomy Catheters, the Reddick Cystic Duct Catheters and the Grice Laparoscopic Sump manufactured by Ideas for Medicine, Inc. The intended use of this device is substantially equivalent in function and intended use to the Fogarty Biliary Balloon Probe, the Edslab Irrigation Catheter, the Ideas for Medicine Trilumen Intravascular Catheter for Gu Use and the Bard Stone Removal Balloon Catheters. These are used to remove ductal debris, stones and exploration of the biliary tree. Irrigation capabilities can facilitate lubrication, flushing and cholangiography.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K954713](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K954713)

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