{"product_id":"fda-510k-k161384-lithoplasty-peripheral-balloon-dilatation-catheter-lithoplasty","title":"FDA 510(k) K161384, Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable, by Shockwave Medical, Inc.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eLithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable\u003c\/strong\u003e (K161384), submitted by Shockwave Medical, Inc..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K161384\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Percutaneous Catheter, Ultrasound\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Shockwave Medical, Inc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 05\/19\/2016\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 09\/14\/2016\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 870.125\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e PPN\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 967 (74 unredacted, 92% 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 80% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 70% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 91% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 79% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 82% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 68% redacted\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 81% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 68% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 25% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 96% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 88% 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":53852132606116,"sku":"FDA510K161384","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-510k-k161384-lithoplasty-peripheral-balloon-dilatation-catheter-lithoplasty.png?v=1791745717","url":"https:\/\/foiadocs.com\/products\/fda-510k-k161384-lithoplasty-peripheral-balloon-dilatation-catheter-lithoplasty","provider":"FOIA Document Source","version":"1.0","type":"link"}