PNEUMOTHORAX KIT, MOTIFICATION— 510(k) K892640

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K892640 for PNEUMOTHORAX KIT, MOTIFICATION, Substantially Equivalent on 1989-10-11. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code JDL
Advisory panel: Orthopedic
Date received: 1989-04-12
Decision date: 1989-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

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.