EasiSlush
System, Perfusion, Kidney
Bridge To Life Ltd.
The following data is part of a premarket notification filed by Bridge To Life Ltd. with the FDA for Easislush.
Pre-market Notification Details
| Device ID | K191006 |
| 510k Number | K191006 |
| Device Name: | EasiSlush |
| Classification | System, Perfusion, Kidney |
| Applicant | Bridge To Life Ltd. 128 Suber Rd. Suite A Columbia, SC 29210 |
| Contact | Tom Keller |
| Correspondent | Richard O. Wood The Wood Burditt Group 10 E. Scranton Ave, Ste 201 Lake Bluff, IL 60044 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-09-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001991208 | K191006 | 000 |
Trademark Results [EasiSlush]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EASISLUSH 87074530 not registered Live/Pending |
Bridge to Life, Ltd. 2016-06-16 |
 EASISLUSH 85725089 not registered Dead/Abandoned |
BTL Solutions, LLC 2012-09-10 |
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