ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025— 510(k) K982141

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K982141 for ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025, Substantially Equivalent on 1998-08-31. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1998-06-17
Decision date: 1998-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.