FDA 510(k) K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75, by Baylis Medical Co., Inc.

FDA 510(k) K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75, by Baylis Medical Co., Inc.

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Device Classification Name: Catheter, Septostomy
510(k) Number: K031949
Device Name: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
Applicant: Baylis Medical Co., Inc.
Regulation Number: 870.5175
Classification Product Code: DXF
Date Received: 06/24/2003
Decision Date: 12/10/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular

Total number of pages: 301
Fully redacted pages: 229
Content pages: 72

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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