LimFlow ARC
Catheter For Crossing Total Occlusions
LimFlow, Inc.
The following data is part of a premarket notification filed by Limflow, Inc. with the FDA for Limflow Arc.
Pre-market Notification Details
| Device ID | K221541 |
| 510k Number | K221541 |
| Device Name: | LimFlow ARC |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | LimFlow, Inc. 3031 Tisch Way - 110 Plaza West San Jose, CA 95128 |
| Contact | Zachary Woodson |
| Correspondent | Zachary Woodson LimFlow, Inc. 3031 Tisch Way - 110 Plaza West San Jose, CA 95128 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-08-31 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850041730011 | K221541 | 000 |
| 00850041730158 | K221541 | 000 |
Trademark Results [LimFlow ARC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIMFLOW ARC 79323331 not registered Live/Pending |
LimFlow SA 2021-08-03 |
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