IV START KIT— 510(k) K844614

Name: FDA 510(k) clearance K844614
Creator: U.S. Food and Drug Administration
Published: 1984-12-19

Substantially Equivalent

Packaging Technologies, Inc.

FDA 510(k) clearance K844614 for IV START KIT, Substantially Equivalent on 1984-12-19. Applicant: Packaging Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Packaging Technologies, Inc.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1984-11-27
Decision date: 1984-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Packaging Technologies, Inc.

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K881756 — STERILE SURGEONS GLOVES1988-06-01
K863326 — BONE MARROW TRAY1986-09-16
K861041 — ENHANCE1986-05-30
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K850438 — RENAL BIOPSY TRAY1985-02-26

Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

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.