MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER— 510(k) K991001

Name: FDA 510(k) clearance K991001
Creator: U.S. Food and Drug Administration
Published: 1999-07-15

Substantially Equivalent

Ep Medsystems

FDA 510(k) clearance K991001 for MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 1999-07-15. Applicant: Ep Medsystems. Device class: 2.

Clearance details

Applicant: Ep Medsystems
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1999-03-25
Decision date: 1999-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: West Berlin, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.