510(k) K140637
K140637 is an FDA 510(k) premarket notification submitted by Ablative Solutions, Inc. for the device "PEREGRINE SYSTEM INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Ablative Solutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2014
- Date Received
- March 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type