CANNULA CLAMP— 510(k) K853538

Name: FDA 510(k) clearance K853538
Creator: U.S. Food and Drug Administration
Published: 1985-09-12

Substantially Equivalent

Cp Medical

FDA 510(k) clearance K853538 for CANNULA CLAMP, Substantially Equivalent on 1985-09-12. Applicant: Cp Medical. Device class: 1.

Clearance details

Applicant: Cp Medical
Product code: Code HXD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-08-23
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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K890381 — PARAMETRIUM CLAMP1989-02-03
K874959 — VASCULAR CLAMP1987-12-30

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Adverse events under product code HXD

product code HXD

Malfunction: 660
Total: 660

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.