510(k) K163618
K163618 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "INDIGO Aspiration System". The FDA issued a decision of SESU on May 24, 2017. The device falls under product code QEX (Coronary Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Penumbra, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- May 24, 2017
- Date Received
- December 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coronary Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.