510(k) K180412
K180412 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister". The FDA issued a decision of Substantially Equivalent on May 15, 2018. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Penumbra, Inc. has 86 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2018
- Date Received
- Feb 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
- 510(k)
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.