RFP-100A Connector Cable (Single Use)— 510(k) K230571

Substantially Equivalent

Baylis Medical Technologies, Inc.

FDA 510(k) clearance K230571 for RFP-100A Connector Cable (Single Use), Substantially Equivalent on 2023-05-30. Applicant: Baylis Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Baylis Medical Technologies, Inc.
Product code
Code DSA
Device class
Class 2
Regulation
21 CFR 870.2900
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mississauga, CA
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSA

product code DSA
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.