FDA 510(k) K022983, BARDPORT X-PORT ISP PORT, by C.R. Bard, Inc.
FDA 510(k) K022983, BARDPORT X-PORT ISP PORT, by C.R. Bard, Inc.
FDA 510(k) records for BARDPORT X-PORT ISP PORT (K022983), submitted by C.R. Bard, Inc..
- 510(k) Number: K022983
- Applicant: C.R. Bard, Inc.
- Decision Date: 09/25/2002
- Decision: Substantially Equivalent (SESE)
- Product Code: LJT LJT
- Review Panel: General Hospital
- Total PDF Pages: 92
- Fully Redacted Pages: 8
- Usable Pages: 84
Sections Included
- Administrative / Introductory Materials: pages 1-2; 0.0% redacted (Unredacted)
- Indications for Use: pages 3-62; 3.3% redacted (Minimal Redaction)
- Substantial Equivalence: pages 63-82; 10.0% redacted (Minimal Redaction)
- Intended Use: pages 83-92; 40.0% redacted (Heavy Redaction)
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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