The following data is part of a premarket notification filed by Silq Technologies Corporation with the FDA for 2-way 100% Silicone Cleartract Catheter.
| Device ID | K221625 |
| 510k Number | K221625 |
| Device Name: | 2-Way 100% Silicone ClearTract Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Silq Technologies Corporation 323 Sunny Isles Blvd Sunny Isles Beach, FL 33160 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron Silq Technologies Corporation 323 Sunny Isles Blvd Sunny Isles Beach, FL 33160 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-07-01 |