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510(k) Data Aggregation
K Number
K021996Device Name
BOLTON PTA CATHETER
Manufacturer
Date Cleared
2002-08-23
(66 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Bolton Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bolton PTA Catheter is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is not intended for use in the coronary arteries.
Device Description
The Bolton PTA Catheter is a single use, dual lumen, percutaneous, angioplasty catheter with a distally mounted semi-compliant balloon for the dilatation of narrowed peripheral vessels. The dual lumen consists of a balloon lumen and a guidewire lumen with two radiopaque to aid in balloon positioning. The catheter is packaged sterile and is nonpyrogenic.
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