Medline Cardiovascular Procedure Kit— 510(k) K212258

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K212258 for Medline Cardiovascular Procedure Kit, Substantially Equivalent on 2021-12-03. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 2021-07-20
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.