The following data is part of a premarket notification filed by Clear Catheter Systems with the FDA for Pleuraflow Catheter System.
| Device ID | K093565 |
| 510k Number | K093565 |
| Device Name: | PLEURAFLOW CATHETER SYSTEM |
| Classification | Wound Drain Catheter System |
| Applicant | CLEAR CATHETER SYSTEMS 901 KING ST., SUITE 200 Alexandria, VA 22314 |
| Contact | Monica Dougherty |
| Correspondent | Monica Dougherty CLEAR CATHETER SYSTEMS 901 KING ST., SUITE 200 Alexandria, VA 22314 |
| Product Code | OTK |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2010-12-03 |
| Summary: | summary |