PROPEP DELIVERY DEVICE— 510(k) K103200

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K103200 for PROPEP DELIVERY DEVICE, Substantially Equivalent on 2011-04-12. Applicant: Rhythmlink International, LLC.

Clearance details

Applicant: Rhythmlink International, LLC
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2010-11-01
Decision date: 2011-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.