Search Results

The Fresenius Single use Arterial Bloodline Sets are intended for use as the extracorporeal blood circuit during normally and high flux negative pressure hemodialyzer equipment. They are intended for single use only.

Not Found

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Fresenius Hemodialysis Single Use Arterial Bloodline Sets).

Here's what the document does provide:

• Device Information: Proprietary Name, Common Name, Product Code/Classification Panel, Classification.
• Manufacturing and Sterilization Sites: Addresses and FDA Establishment Registration Numbers.
• Submitter Information: Name, address, and FDA Establishment Registration Number.
• Contact Information: Names, telephone, and fax numbers.
• Summary of Safety and Effectiveness: States that this is provided in Appendix 1 (not included in the input).
• Performance Standards: States no applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act for Blood Tubing Sets.
• Compliance with ANSI/AAMI RD17-1994: States the device has been designed to meet requirements for Hemodialyzer Blood Tubing as specified in ANSI/AAMI RD17-1994. This is the closest the document comes to mentioning a standard, but it doesn't detail specific acceptance criteria or a study proving compliance.
• Predicate Devices: Lists previously cleared Fresenius blood tubing sets.
• FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use/Intended Use: Description of how the device is intended to be used.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text.

Ask a specific question about this device