510(k) K160450
K160450 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "Pleurx Pleural Catheter System". The FDA issued a decision of Substantially Equivalent on Oct 31, 2016. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Care Fusion has 33 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 2016
- Date Received
- Feb 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Patient Care
- Device Class
- Class II
- Regulation Number
- 870.5050
- Review Panel
- AN
- Submission Type
- 510(k)