510(k) K201806
K201806 is an FDA 510(k) premarket notification submitted by Sterilmed Inc. (Johnson and Johnson) for the device "Reprocessed PentaRay Nav eco High-Density Mapping Catheter". The FDA issued a decision of Substantially Equivalent on June 23, 2021. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2021
- Date Received
- July 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type