• FDA 510(k) records for MobileRay Pulse SE Digital Imaging System K191503
1 1

FDA 510(k) K233407, AtriClip LAA Exclusion System Family (Gillinov-Cosgrove, PRO-V and Flex-V), by AtriCure, Inc.

FDA 510(k) K233407, AtriClip LAA Exclusion System Family (Gillinov-Cosgrove, PRO-V and Flex-V), by AtriCure, Inc.

$89.00 USD
$89.00 USD
Sale Sold out

FDA 510(k) records for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (K233407), submitted by AtriCure, Inc..

  • 510(k) Number: K233407
  • Applicant: AtriCure, Inc.
  • Decision Date: 11/02/2023
  • Decision: Substantially Equivalent (SESE)
  • Product Code: PZX PZX
  • Review Panel: Cardiovascular
  • Total PDF Pages: 519
  • Fully Redacted Pages: 336
  • Usable Pages: 183

Sections Included

  • Administrative / Introductory Materials: pages 1-362; 79.0% redacted (Heavy Redaction)
  • Indications for Use: pages 363-391; 17.2% redacted (Moderate Redaction)
  • Performance Testing: pages 392-404; 15.4% redacted (Moderate Redaction)
  • Indications for Use: pages 405-408; 0.0% redacted (Unredacted)
  • Performance Testing: pages 409; 0.0% redacted (Unredacted)
  • Indications for Use: pages 410-513; 39.4% redacted (Heavy Redaction)
  • Performance Testing: pages 514-519; 33.3% redacted (Moderate Redaction)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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