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The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Trans Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters with cuff sizes ranging from 10.8 french to 14.5 french.

The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters.

There is no information in the provided document about acceptance criteria, device performance details, or any study conducted to prove the device meets acceptance criteria.

The document is an FDA 510(k) clearance letter for the "Trans Catheter Extractor" (K063048). This letter indicates that the device has been found substantially equivalent to a predicate device already on the market, allowing the applicant to market the device.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)..."

Therefore, based solely on the provided text, I cannot answer the specific questions regarding acceptance criteria and study details. This document is a regulatory approval letter, not a scientific study report.

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