510(k) K191733
- Device
- The ZIP Accessory Shuttle For PleuraFlow System
- Applicant
- ClearFlow, Inc.
- 510(k) number
- K191733
- Product code
- OTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-26
- Date received
- 2019-06-28
- Regulation
- 878.4780
- Classification name
- Wound Drain Catheter System
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dov Gal
- Address
- 1630 S. Sunkist St. Suite E Anaheim CA US 92806 92806
FDA Registration Numbers#
- 3008782989
- 2025851
Source Documents#
Other 510(k) Records For Product Code OTK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2021-03-02 |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | 2018-08-14 |
| K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016-11-30 |
| K153681 | PleuraFlow System | Clearflow, Inc. | 2016-01-20 |
| K150042 | PleuraFlow System | Clearflow, Inc. | 2015-06-02 |
| K093565 | PLEURAFLOW CATHETER SYSTEM | Clear Catheter Systems | 2010-12-03 |
Legacy Summary#
summary
FDA Review#
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