FDA 510(k) K201271, Benchmark BMX96 Access System, by Penumbra, Inc.

FDA 510(k) K201271, Benchmark BMX96 Access System, by Penumbra, Inc.

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Device Classification Name: Catheter, Percutaneous
510(k) Number: K201271
Device Name: Benchmark BMX96 Access System
Applicant: Penumbra, Inc.
Regulation Number: 870.125
Classification Product Code: DQY
Date Received: 2020-05-12
Decision Date: 2020-06-11
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Neurology

Total number of pages: 453
Fully redacted pages: 288
Content pages: 165

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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