L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER— 510(k) K974543

Substantially Equivalent

Luther Medical Products, Inc.

FDA 510(k) clearance K974543 for L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER, Substantially Equivalent on 1998-02-10. Applicant: Luther Medical Products, Inc..

Clearance details

Applicant: Luther Medical Products, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1997-12-03
Decision date: 1998-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.