PLEURAFLOW CATHETER SYSTEM
FDA 510(k) clearance K093565 · decided 2010-12-03
Clearance details
- K-number
- K093565
- Device name
- PLEURAFLOW CATHETER SYSTEM
- Applicant
- Clear Catheter Systems
- Decision
- Substantially Equivalent
- Date received
- 2009-11-18
- Decision date
- 2010-12-03
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- OTK
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alexandria, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PleuraFlow System with FlowGlide (K203394) | Clearflow, Inc. | 2021-03-02 |
| The ZIP Accessory Shuttle for PleuraFlow System (K191733) | Clearflow, Inc. | 2019-07-26 |
| PleuraFlow System with FlowGlide Extra Drainage Length (K182067) | Clearflow, Inc. | 2018-08-14 |
| PleuraFlow System with FlowGlide (K163139) | Clearflow, Inc. | 2016-11-30 |
| PleuraFlow System (K153681) | Clearflow, Inc. | 2016-01-20 |
| PleuraFlow System (K150042) | Clearflow, Inc. | 2015-06-02 |
Recalls involving this device
No recalls on record reference this clearance.