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510(k) Data Aggregation
K Number
K163388Device Name
XPress BCD Breast Compression Device
Manufacturer
Date Cleared
2017-07-19
(229 days)
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
XPress BCD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xpress BCD is a reusable device indicated for use with stereotactic biopsy platforms to apply temporary focal mechanical compression to a stereotactic breast biopsy site to achieve hemostasis. Rx Only. Federal (USA) law restricts this device to sale by or on the order of a physician.
Device Description
The XPress BCD device is an accessory used in conjunction stereotactic breast biopsy devices. The XPress BCD is comprised of Delrin® DuPont (acetal homopolymer resin, Delrin 150NC010), or similar material. There are three (3) independent XPress BCD device configurations that are provided as a set: configuration 1 (large flat), configuration 2 (modified pyramidal), and configuration 3 (modified spherical). These different configurations are used based on the biopsy site being treated. The Xpress design includes a mechanical slot for attaching to compression paddles of mammographic x-ray systems. The XPress BCD is used in conjunction with the XPress BCD Cover (K863853; classification JAA; manufactured by Preferred Medical Products, Ducktown, TN). It is used to enclose the XPress BCD for use as intended. The XPress BCD Cover, is a sterile, single-use covering. The XPress BCD Cover is a 4 X 5 inches covering of a 0.002 mm thick polyethylene blend material, and its closure system is a round or oblong synthetic rubber band made of a polyisoprene polymer, measuring 2 X 1/8 X 1/16 inches. The XPress BCD Cover is packaged with the XPress BCD or may be purchased separately.
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