FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, C.R. BARD, INC.
FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, C.R. BARD, INC.
Device Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
Manufacturer: C.R. BARD, INC.
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 09/21/2012
Decision Date: 11/15/2012
Regulation Medical Specialty: General Hospital
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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