{"product_id":"fda-510k-k202345-flowtriever-retrievalaspiration-system","title":"FDA 510(k) K202345, FlowTriever Retrieval\/Aspiration System, by Inari Medical","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eFlowTriever Retrieval\/Aspiration System\u003c\/strong\u003e (K202345), submitted by Inari Medical.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K202345\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Peripheral Mechanical Thrombectomy With Aspiration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Inari Medical\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 08\/18\/2020\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 12\/18\/2020\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 870.515\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e QEW\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 323 (120 unredacted, 62% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e~ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 33% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 25% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 38% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 36% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 29% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 38% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 75% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 37% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 32% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 38% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 42% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 50% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":53852133097636,"sku":"FDA510K202345","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-510k-k202345-flowtriever-retrievalaspiration-system.png?v=1791745411","url":"https:\/\/foiadocs.com\/products\/fda-510k-k202345-flowtriever-retrievalaspiration-system","provider":"FOIA Document Source","version":"1.0","type":"link"}