(149 days)
The ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.
WorkHorse™ Percutaneous Transluminal Angioplasty Balloon Catheter
This document is a 510(k) clearance letter from the FDA for a medical device called the "WorkHorse™ Percutaneous Transluminal Angioplasty Balloon Catheter." It is dated September 29, 1999.
This document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
This type of FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, and does not raise different questions of safety and effectiveness. The 510(k) process typically relies on demonstrating substantial equivalence rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria as might be seen for a PMA (Premarket Approval) submission.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The document is solely a regulatory clearance letter.
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).