Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable— 510(k) K183649
Substantially EquivalentBaylis Medical Company, Inc.
FDA 510(k) clearance K183649 for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable, Substantially Equivalent on 2019-06-07. Applicant: Baylis Medical Company, Inc.. Device class: 2.
Clearance details
- Applicant
- Baylis Medical Company, Inc.
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code DRF
view allMore clearances from Baylis Medical Company, Inc.
view allAdverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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.