510(k) K152335
K152335 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Export Advance Aspiration Catheter". The FDA issued a decision of Substantially Equivalent on September 18, 2015. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2015
- Date Received
- August 19, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type