INFLATION PRO II— 510(k) K895836

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K895836 for INFLATION PRO II, Substantially Equivalent on 1989-12-20. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1989-10-03
Decision date: 1989-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.