ClearLine IV
Intravascular Administration Set, Automated Air Removal System
ClearLine MD
The following data is part of a premarket notification filed by Clearline Md with the FDA for Clearline Iv.
Pre-market Notification Details
| Device ID | K171954 |
| 510k Number | K171954 |
| Device Name: | ClearLine IV |
| Classification | Intravascular Administration Set, Automated Air Removal System |
| Applicant | ClearLine MD 300 TradeCenter, Suite 5400 Woburn, MA 01801 |
| Contact | Rick Romeo |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | OKL |
| CFR Regulation Number | 880.5445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2018-01-25 |
| Summary: | summary |
Trademark Results [ClearLine IV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARLINE IV 87099993 5351479 Live/Registered |
CLEARLINE MD, LLC 2016-07-11 |
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