DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM— 510(k) K953651

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K953651 for DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM, Substantially Equivalent on 1995-11-30. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1995-08-04
Decision date: 1995-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, 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.