NAMIC SELDINGER INTRODUCER NEEDLE— 510(k) K871378

Name: FDA 510(k) clearance K871378
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K871378 for NAMIC SELDINGER INTRODUCER NEEDLE, Substantially Equivalent on 1987-05-06. Applicant: North American Instrument Corp.. Device class: 2.

Clearance details

Applicant: North American Instrument Corp.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 1987-04-07
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

Download summary PDF View on FDA.gov ↗

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K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS1993-03-03
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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.