Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
FDA 510(k) clearance K241224 · decided 2024-11-15
Clearance details
- K-number
- K241224
- Device name
- Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- Applicant
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Decision
- Substantially Equivalent
- Date received
- 2024-05-02
- Decision date
- 2024-11-15
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- NLH
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2m recall (Z-1319-2026) | Medline Industries, LP | 2026-02-06 |
| Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac recall (Z-2611-2025) | Medline Industries, LP | 2025-09-26 |