510(k) K131998
K131998 is an FDA 510(k) premarket notification submitted by Control Medical Technology, LLC for the device "ASPIRE RX-LP6 ASPIRATION CATHETER". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Control Medical Technology, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 2013
- Date Received
- June 28, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.