FDA 510(k) K213657, DEEPVESSEL FFR, by Keyamed Na, Inc.

FDA 510(k) K213657, DEEPVESSEL FFR, by Keyamed Na, Inc.

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Device Classification Name: Coronary Vascular Physiologic Simulation Software
510(k) Number: K213657
Device Name: DEEPVESSEL FFR
Applicant: Keyamed Na, Inc.
Regulation Number: 870.1415
Classification Product Code: PJA
Date Received: 11/19/2021
Decision Date: 04/01/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular

Total number of pages: 1,057
Fully redacted pages: 819
Content pages: 238

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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