SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX— 510(k) K042538

Substantially Equivalent

Invatec Innovative Technologies

FDA 510(k) clearance K042538 for SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX, Substantially Equivalent on 2004-11-08. Applicant: Invatec Innovative Technologies.

Clearance details

Applicant: Invatec Innovative Technologies
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2004-09-20
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.