FDA Product Code
FDA Product Code OTK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4780
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2021-03-02 | Special | PDF ↗ |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019-07-26 | Special | PDF ↗ |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | 2018-08-14 | Special | PDF ↗ |
| K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016-11-30 | Special | PDF ↗ |
| K153681 | PleuraFlow System | Clearflow, Inc. | 2016-01-20 | Special | PDF ↗ |
| K150042 | PleuraFlow System | Clearflow, Inc. | 2015-06-02 | Traditional | PDF ↗ |
| K093565 | PLEURAFLOW CATHETER SYSTEM | Clear Catheter Systems | 2010-12-03 | Traditional | PDF ↗ |
Product code OTK · Class II · General, Plastic Surgery. Data: openFDA.