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並前往https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K971034

510(k) Premarket Notification - FDA

Device Classification Name, catheter, intravascular, diagnostic 22. 510(k) Number, K971034. Device Name, USCI MAINSTAY GUIDING CATHETER.

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