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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K171997
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Product Description
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FDA Recall
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Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-... 2 09/28/2022 Cook Incorporated
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G... 2 09/28/2022 Cook Incorporated
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG... 2 09/28/2022 Cook Incorporated
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