The following data is part of a premarket notification filed by Clearflow, Inc. with the FDA for Pleuraflow System With Flowglide.
| Device ID | K163139 |
| 510k Number | K163139 |
| Device Name: | PleuraFlow System With FlowGlide |
| 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 | 2016-11-09 |
| Decision Date | 2016-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20856449006080 | K163139 | 000 |
| 20856449006073 | K163139 | 000 |
| 20856449006066 | K163139 | 000 |
| 20856449006059 | K163139 | 000 |
| 20856449006127 | K163139 | 000 |
| 00856449006147 | K163139 | 000 |
| 20856449006110 | K163139 | 000 |