PHARMASEAL WOUND IRRIGATION DEVICE— 510(k) K874022

Name: FDA 510(k) clearance K874022
Creator: U.S. Food and Drug Administration
Published: 1987-12-30

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K874022 for PHARMASEAL WOUND IRRIGATION DEVICE, Substantially Equivalent on 1987-12-30. Applicant: American Pharmaseal Div. Ahsc. Device class: 2.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 1987-10-02
Decision date: 1987-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM1987-09-04
K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER1987-08-11

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.