FLUTTER(R)— 510(k) K946083

Substantially Equivalent

Bradstreet Clinical Research Assoc., Inc.

FDA 510(k) clearance K946083 for FLUTTER(R), Substantially Equivalent on 1995-03-13. Applicant: Bradstreet Clinical Research Assoc., Inc..

Clearance details

Applicant: Bradstreet Clinical Research Assoc., Inc.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 1994-12-13
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brunswick, NJ, US

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.