SUBCLAVIAN JUGULAR CATHETER SET— 510(k) K820102

Substantially Equivalent

Luther Medical Products, Inc.

FDA 510(k) clearance K820102 for SUBCLAVIAN JUGULAR CATHETER SET, Substantially Equivalent on 1982-01-29. Applicant: Luther Medical Products, Inc..

Clearance details

Applicant: Luther Medical Products, Inc.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1982-01-15
Decision date: 1982-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.