510(k) K203394
K203394 is an FDA 510(k) premarket notification submitted by Clearflow, Inc. for the device "PleuraFlow System with FlowGlide". The FDA issued a decision of Substantially Equivalent on Mar 2, 2021. The device falls under product code OTK (Wound Drain Catheter System), a Class II device regulated under 21 CFR 878.4780. Clearflow, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 2021
- Date Received
- Nov 18, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Drain Catheter System
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)
For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.