← Product Code [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT) · K961980 # BIPORE BALLOON DILATATION CATHETER (K961980) _Bipore, Inc. · LIT · Sep 12, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K961980 ## Device Facts - **Applicant:** Bipore, Inc. - **Product Code:** [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT.md) - **Decision Date:** Sep 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## 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. ## 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. ## Regulatory 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](/device/K897106.md)) - Medi-tech Ultra-Thin Balloon Dilatation Catheter ([K920547](/device/K920547.md)) ## 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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K961980](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K961980) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com