Search Results

The Vascular Closure Device indications for use are to approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wound or puncture site to aid healing in minimally invasive or open procedures for full body applications.

See Product Description Section on pages 17 and 18.

This document is a 510(k) summary for a Vascular Closure Device. It does not contain information about acceptance criteria or a study proving its performance.

The provided text is a summary prepared for a 510(k) Pre-Market Notification, specifically for a "Special 510(K)" submission. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria, as might be found in a De Novo or PMA submission.

The core information presented is:

• Device Name: Vascular Closure Device
• Manufacturer: STD Manufacturing, Inc.
• Indication for Use: To approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wounds or puncture sites to aid healing in minimally invasive or open procedures for full body applications.
• Substantial Equivalence Claim: The device is substantially equivalent to a Vascular Closure Device cleared under K#003169.
• FDA Clearance: The FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be extracted from this document. This information is typically part of a more extensive technical file or premarket application, which is summarized in the K012362 document.

Ask a specific question about this device

Ask a specific question about this device