TYGON PAC-STOPCOCKS— 510(k) K770708

Name: FDA 510(k) clearance K770708
Creator: U.S. Food and Drug Administration
Published: 1977-06-08

Substantially Equivalent

Norton Performance Plastics Corp.

FDA 510(k) clearance K770708 for TYGON PAC-STOPCOCKS, Substantially Equivalent on 1977-06-08. Applicant: Norton Performance Plastics Corp.. Device class: 2.

Clearance details

Applicant: Norton Performance Plastics Corp.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1977-04-18
Decision date: 1977-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K851299 — CORRECT FLO1985-05-07
K842858 — FLUID ADMINISTRATION LINE W/SPIKE 14-9231984-09-11
K841828 — CENTRAL VENOUS CATHETER W/BIG-GARD1984-07-13

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.