510(k) K190619
K190619 is an FDA 510(k) premarket notification submitted by Meril Life Sciences Private Limited for the device "Aspiron(TM) Aspiration Catheter". The FDA issued a decision of Substantially Equivalent on Apr 29, 2019. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Meril Life Sciences Private Limited has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 2019
- Date Received
- Mar 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
- 510(k)
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.