Who is the manufacturer of DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)?

Ideas For Medicine, Inc. filed the 510(k) submission for DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) (K954713).

What is the FDA product code for DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)?

FGE. It is classified under 21 CFR 876.5010 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)?

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

Who can help prepare an FDA 510(k) submission like DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

K954713 · Ideas For Medicine, Inc. · FGE · Jul 24, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K954713
Device Name	DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
Applicant	Ideas For Medicine, Inc.
Product Code	FGE · Gastroenterology, Urology
Decision Date	Jul 24, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5010
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for patients requiring removal of biliary stones, ductal debris, or exploration of the biliary tree.

Regulatory Classification

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

Related Devices

K091495 — SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A · Olympus Medical Systems Corporation · Sep 3, 2009
K253132 — Single use stone retrieval balloons · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 6, 2026
K131642 — RSH BILIARY STONE REMOVAL DEVICE · Rsh, LLC · Aug 7, 2013
K210660 — Stone Retrieval Balloon Catheter · Anrei Medical (Hangzhou) Co., Ltd. · Apr 27, 2021
K170292 — Tri-Ex Extraction Balloon With Multiple Sizing · Wilson-Cook Medical, Inc. · Sep 20, 2017

Submission Summary (Full Text)

{0} 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. 24