• FDA 510(k) records for SONICAID SYSTEM 8002 K992607
1 1

FDA 510(k) K100451, Gamcath High Flow Dolphin Ms-Gdhc-1315 A; and Ms-Gdhc-1315j A, Gamcath High Flow Dolphin Ms-Gdhc-1320 A; and Ms-Gdhc-132, by Gambro Renal Products, Inc.

FDA 510(k) K100451, Gamcath High Flow Dolphin Ms-Gdhc-1315 A; and Ms-Gdhc-1315j A, Gamcath High Flow Dolphin Ms-Gdhc-1320 A; and Ms-Gdhc-132, by Gambro Renal Products, Inc.

$89.00 USD
$89.00 USD
Sale Sold out

FDA 510(k) records for GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451), submitted by Gambro Renal Products, Inc..

  • 510(k) Number: K100451
  • Applicant: Gambro Renal Products, Inc.
  • Decision Date: 12/21/2010
  • Decision: Substantially Equivalent (SESE)
  • Product Code: MPB MPB
  • Review Panel: Gastroenterology/Urology
  • Total PDF Pages: 964
  • Fully Redacted Pages: 465
  • Usable Pages: 499

Sections Included

  • Administrative / Introductory Materials: pages 1-11; 63.6% redacted (Heavy Redaction)
  • Indications for Use: pages 12-199; 60.6% redacted (Heavy Redaction)
  • 510(k) Summary: pages 200; 0.0% redacted (Unredacted)
  • Device Description: pages 201; 0.0% redacted (Unredacted)
  • Indications for Use: pages 202-233; 62.5% redacted (Heavy Redaction)
  • CDRH Premarket Review Submission Cover Sheet: pages 234-237; 25.0% redacted (Moderate Redaction)
  • Standards: pages 238-242; 20.0% redacted (Moderate Redaction)
  • Indications for Use: pages 243-285; 53.5% redacted (Heavy Redaction)
  • Intended Use: pages 286-360; 65.3% redacted (Heavy Redaction)
  • Clinical Testing: pages 361-571; 83.4% redacted (Heavy Redaction)
  • Indications for Use: pages 572; 0.0% redacted (Unredacted)
  • 510(k) Summary: pages 573-596; 54.2% redacted (Heavy Redaction)
  • Device Description: pages 597; 0.0% redacted (Unredacted)
  • Indications for Use: pages 598-964; 16.6% 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