510(k) K121158
K121158 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS". The FDA issued a decision of Substantially Equivalent on August 6, 2012. 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
- August 6, 2012
- Date Received
- April 16, 2012
- 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).