The following data is part of a premarket notification filed by Clearflow, Inc. with the FDA for Pleuraflow System With Flowglide Extra Drainage Length.
| Device ID | K182067 |
| 510k Number | K182067 |
| Device Name: | PleuraFlow System With FlowGlide Extra Drainage Length |
| Classification | Wound Drain Catheter System |
| Applicant | ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim, CA 92806 |
| Contact | Dov Gal |
| Correspondent | Dov Gal ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim, CA 92806 |
| Product Code | OTK |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-08-14 |
| Summary: | summary |