ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65— 510(k) K990829

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K990829 for ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65, Substantially Equivalent on 1999-05-04. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1999-03-12
Decision date: 1999-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.