510(k) K211662
K211662 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed IntellaMap Orion High Resolution Mapping Catheter". The FDA issued a decision of Substantially Equivalent on November 18, 2021. The device falls under product code NLG (Catheter, Intracardiac Mapping, High-Density, Reprocessed), a Class II device regulated under 21 CFR 870.1220. Innovative Health, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2021
- Date Received
- June 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density, 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).