BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE— 510(k) K990284

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K990284 for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE, Substantially Equivalent on 2001-02-01. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 1999-01-29
Decision date: 2001-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

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.