SELDINGER PERCUTANEOUS 2 PC NEEDLES— 510(k) K895455

Name: FDA 510(k) clearance K895455
Creator: U.S. Food and Drug Administration
Published: 1989-11-14

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K895455 for SELDINGER PERCUTANEOUS 2 PC NEEDLES, Substantially Equivalent on 1989-11-14. Applicant: Advance Medical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 1989-09-05
Decision date: 1989-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.