ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.— 510(k) K882289

Substantially Equivalent

Aries Medical, Inc.

FDA 510(k) clearance K882289 for ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH., Substantially Equivalent on 1988-12-12. Applicant: Aries Medical, Inc..

Clearance details

Applicant: Aries Medical, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1988-06-01
Decision date: 1988-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.