K203394 is an FDA 510(k) clearance for the PleuraFlow System with FlowGlide. This device is classified as a Wound Drain Catheter System (Class II - Special Controls, product code OTK).
Submitted by Clearflow, Inc. (Irvine, US). The FDA issued a Cleared decision on March 2, 2021, 104 days after receiving the submission on November 18, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780. 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..
| 510(k) Number | K203394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2020 |
| Decision Date | March 02, 2021 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OTK - Wound Drain Catheter System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |
| Definition | 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. |