510(k) K911070— PICC-FIX

Substantially Equivalent

Sorex Medical

Clearance details

Applicant: Sorex Medical
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1991-03-11
Decision date: 1991-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.