FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter

FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter

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510(K) Number: K171277
Device Name: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Manufacturer: Innovative Health, LLC.
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Regulation Number: 870.1220
Classification Product Code: DRF
Date Received: 05/01/2017
Decision Date: 10/23/2017
Regulation Medical Specialty: Cardiovascular

Total pages: 2,735
Fully redacted pages: 2,702
Content pages: 33

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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