FDA 510(k) K181642, B-Laser Atherectomy System, by Eximo Medical, Ltd.
FDA 510(k) K181642, B-Laser Atherectomy System, by Eximo Medical, Ltd.
Device Classification Name: Catheter, Peripheral, Atherectomy
510(k) Number: K181642
Device Name: B-Laser Atherectomy System
Applicant: Eximo Medical, Ltd.
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 06/21/2018
Decision Date: 10/05/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 2,851
Fully redacted pages: 2,560
Content pages: 291
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details