Who is the manufacturer of BIPORE BALLOON DILATATION CATHETER?

Bipore, Inc. filed the 510(k) submission for BIPORE BALLOON DILATATION CATHETER (K961980).

What is the FDA product code for BIPORE BALLOON DILATATION CATHETER?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BIPORE BALLOON DILATATION CATHETER?

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

What are the predicate devices for BIPORE BALLOON DILATATION CATHETER?

Medi-tech Ultra-Thin Balloon Dilatation Catheter (K897106); Medi-tech Ultra-Thin Balloon Dilatation Catheter (K920547).

Who can help prepare an FDA 510(k) submission like BIPORE BALLOON DILATATION CATHETER?

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.

BIPORE BALLOON DILATATION CATHETER

K961980 · Bipore, Inc. · LIT · Sep 12, 1996 · Cardiovascular

Device Facts

Record ID	K961980
Device Name	BIPORE BALLOON DILATATION CATHETER
Applicant	Bipore, Inc.
Product Code	LIT · Cardiovascular
Decision Date	Sep 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

Device Story

Double lumen balloon dilatation catheter; used for percutaneous transluminal angioplasty (PTA) in peripheral vessels. One lumen facilitates balloon inflation/deflation; second lumen allows tracking over guidewire to stenosis site. Available in 6mm, 8mm, and 10mm balloon diameters; 4cm balloon length; 5Fr catheter size; 100cm usable length. Operated by clinicians in clinical settings to dilate obstructive lesions. Benefits include restoration of vessel patency and improved blood flow in peripheral arteries and dialysis fistulae.

Clinical Evidence

Bench testing only. In vitro functional testing included balloon burst, multiple inflation, compliance, and inflation/deflation time. Biocompatibility testing included systemic toxicity, intracutaneous toxicity, implantation, hemolysis, and cytotoxicity.

Technological Characteristics

Double lumen catheter design. Materials unspecified. Available in 5Fr size, 100cm length. Balloon diameters: 6, 8, 10mm; length: 4cm. Mechanical inflation/deflation mechanism. No software or electronic components.

Indications for Use

Indicated for patients requiring Transluminal Percutaneous Angioplasty (PTA) of iliac, femoral, or renal arteries, or treatment of obstructive lesions in autologous or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Medi-tech Ultra-Thin Balloon Dilatation Catheter (K897106)
Medi-tech Ultra-Thin Balloon Dilatation Catheter (K920547)

Related Devices

K020854 — MODIFICATION TO FOX PTA CATHETER · Jomed AG · Apr 11, 2002
K050389 — ULTRA-SOFT SV BALLOON DILATATION CATHETER · Boston Scientific Corp · May 25, 2005
K992825 — CORDIS EXTREME PTA BALLOON CATHETER · Cordis Corp. · Sep 15, 1999
K202800 — Pacific Plus PTA Catheter · Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) · Nov 18, 2020
K980390 — PTA BALLOON CATHETER · Cook, Inc. · Aug 20, 1998

Submission Summary (Full Text)

{0} SEP 12 1996 K961980 # SUMMARY OF SAFETY AND EFFECTIVENESS ## BIPORE BALLOON DILATATION CATHETER ### May 15, 1996 **Trade Name:** Bipore Balloon Dilatation Catheter **Manufacturer:** Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647 Tel: (201) 767-1993 Fax: (201) 767-0435 **Device Generic Name:** Balloon Dilatation Catheter **Classification:** Class II, Performance Standards **Predicate Devices:** Medi-tech Ultra-Thin Balloon Dilatation Catheter 510(k): K897106 and K920547 **Description of Device:** The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis. The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows: | Inflated Balloon Diameter (mm) | Balloon Length (cm) | Catheter Size (Fr) | Usable Length (cm) | | --- | --- | --- | --- | | 6 | 4 | 5 | 100 | | 8 | 4 | 5 | 100 | | 10 | 4 | 5 | 100 | **Indications for Use:** The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae. {1} Safety and Performance: The following *in vitro* functional tests were performed on the Bipore Balloon Dilatation Catheter: - Balloon Burst - Balloon Multiple Inflation - Balloon Compliance - Balloon Inflation/Deflation Time The following biocompatibility tests were performed: - Systemic Toxicity - Intracutaneous Toxicity - Implantation - Hemolysis - Cytotoxicity Conclusion: Based on the indications for use, technological characteristics, and safety and performance tests, it has been demonstrated that the Bipore Balloon Dilatation Catheter is safe and effective for its intended use.