PROCATH PACING THRESHOLD CABLE— 510(k) K941058

Substantially Equivalent

Professional Catheter Corp.

FDA 510(k) clearance K941058 for PROCATH PACING THRESHOLD CABLE, Substantially Equivalent on 1994-07-11. Applicant: Professional Catheter Corp..

Clearance details

Applicant: Professional Catheter Corp.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1994-03-08
Decision date: 1994-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, NJ, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.