ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000— 510(k) K022348

Name: FDA 510(k) clearance K022348
Creator: U.S. Food and Drug Administration
Published: 2002-08-15

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K022348 for ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000, Substantially Equivalent on 2002-08-15. Applicant: Interpore Cross Intl.. Device class: 2.

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2002-07-19
Decision date: 2002-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.