CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221— 510(k) K030398

Clearance details

Applicant

Cardiacassist, Inc.

Product code

Code DQR

Device class

Class 2

Regulation

21 CFR 870.1300

Advisory panel

Cardiovascular

Date received

2003-02-06

Decision date

2003-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pittsburgh, PA, US

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Death

2

Total

2

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 →