510(k) K153006
K153006 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter". The FDA issued a decision of Substantially Equivalent on June 23, 2016. The device falls under product code NLH (Catheter, Recording, Electrode, Reprocessed), a Class II device regulated under 21 CFR 870.1220. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2016
- Date Received
- October 14, 2015
- 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).