• FDA 510(k) records for CT HILIGHT ADVANTAGE K894269
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FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, by C.R. Bard, Inc.

FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, by C.R. Bard, Inc.

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FDA 510(k) records for POWERPORT CLEARVUE SLIM IMPLANTABLE PORT (K122899), submitted by C.R. Bard, Inc..

  • 510(k) Number: K122899
  • Applicant: C.R. Bard, Inc.
  • Decision Date: 11/15/2012
  • Decision: Substantially Equivalent (SESE)
  • Product Code: LJT LJT
  • Review Panel: General Hospital
  • Total PDF Pages: 907
  • Fully Redacted Pages: 577
  • Usable Pages: 330

Sections Included

  • Administrative / Introductory Materials: pages 1-215; 96.7% redacted (Heavy Redaction)
  • Labeling: pages 216-225; 0.0% redacted (Unredacted)
  • Indications for Use: pages 226-251; 0.0% redacted (Unredacted)
  • Intended Use: pages 252-501; 64.0% redacted (Heavy Redaction)
  • 510(k) Summary: pages 502-505; 0.0% redacted (Unredacted)
  • Indications for Use: pages 506-538; 42.4% redacted (Heavy Redaction)
  • CDRH Premarket Review Submission Cover Sheet: pages 539-541; 0.0% redacted (Unredacted)
  • 510(k) Statement: pages 542-552; 0.0% redacted (Unredacted)
  • Indications for Use: pages 553-556; 0.0% redacted (Unredacted)
  • 510(k) Summary: pages 557-601; 2.2% redacted (Minimal Redaction)
  • Device Description: pages 602-622; 9.5% redacted (Minimal Redaction)
  • Substantial Equivalence: pages 623-632; 0.0% redacted (Unredacted)
  • Labeling: pages 633-642; 10.0% redacted (Minimal Redaction)
  • Biocompatibility: pages 643-649; 0.0% redacted (Unredacted)
  • Software: pages 650-907; 74.0% redacted (Heavy 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

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