K241334
- 510(k) number
- K241334
- Device name
- Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
- Applicant
- C.R. Bard, Inc. GA · US
- Product code
- LDF — Electrode, Pacemaker, Temporary
- Decision date
- 2025-01-31
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241334.pdf
Official FDA record: K241334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.