FDA 510(k), K101542, HEADWAY 17 ADVANCED MICROCATHETER

FDA 510(k), K101542, HEADWAY 17 ADVANCED MICROCATHETER

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510(K) Number: K101542
Device Name: HEADWAY 17 ADVANCED MICROCATHETER
Manufacturer: MICROVENTION, INC.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 06/03/2010
Decision Date: 08/06/2010
Regulation Medical Specialty: Cardiovascular

Total pages: 541
Fully redacted pages: 341
Content pages: 200

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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