FDA 510(k), K052257, VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER

FDA 510(k), K052257, VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER

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510(K) Number: K052257
Device Name: VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
Manufacturer:
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 08/18/2005
Decision Date: 11/23/2005
Regulation Medical Specialty: Cardiovascular

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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