FDA 510(k), K173761, Penumbra System Reperfusion Catheter JET 7

FDA 510(k), K173761, Penumbra System Reperfusion Catheter JET 7

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510(K) Number: K173761
Device Name: Penumbra System Reperfusion Catheter JET 7
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 12/11/2017
Decision Date: 08/17/2018
Regulation Medical Specialty: Cardiovascular

Total pages: 2,573
Fully redacted pages: 1,920
Content pages: 653

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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