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FDA 510(k) K130798, PRE-FORMED GUIDEWIRES, by Lake Region Medical, Inc.

FDA 510(k) K130798, PRE-FORMED GUIDEWIRES, by Lake Region Medical, Inc.

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510(K) Number: K130798
Device Name: PRE-FORMED GUIDEWIRES
Manufacturer: Lake Region Medical, Inc.
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 03/22/2013
Decision Date: 08/23/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

Total pages: 2,691  
Fully redacted pages: 2,023  
Content pages: 668  

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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