DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE— 510(k) K011361

Substantially Equivalent

Catheffects, LLC

FDA 510(k) clearance K011361 for DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE, Substantially Equivalent on 2001-09-06. Applicant: Catheffects, LLC.

Clearance details

Applicant: Catheffects, LLC
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2001-05-03
Decision date: 2001-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

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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.