510(k) K241224
K241224 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren for the device "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)". The FDA issued a decision of Substantially Equivalent on November 15, 2024. The device falls under product code NLH (Catheter, Recording, Electrode, Reprocessed), a Class II device regulated under 21 CFR 870.1220. Surgical Instrument Service and Savings Inc.(Dba Medline Ren has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2024
- Date Received
- May 2, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Recording, Electrode, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).