FDA 510(k), K180329, ClotTriever Thrombectomy System

FDA 510(k), K180329, ClotTriever Thrombectomy System

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510(K) Number: K180329
Device Name: ClotTriever Thrombectomy System
Manufacturer: Inari Medical, Inc.
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 02/06/2018
Decision Date: 04/09/2018
Regulation Medical Specialty: Cardiovascular

Total pages: 202  
Fully redacted pages: 93  
Content pages: 109 

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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