FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Contents: Correspondence, Substantially Equivalence Mapping, 510k Summary, 510K Screening Checklist, Device Comparison Table, Third Party Review Checklist, Labeling, Indications for Use, Instructions for Use, Extent of Standard Conformance Summary Report Table
510(K) Number: K111738
Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Manufacturer: SHIVA ARDAKAMI
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: KXA
Date Received: 06/21/2011
Decision Date: 12/14/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
144 pages (701 of 845 original pages are fully redacted)
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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