The following data is part of a premarket notification filed by Silq Technologies, Corp. with the FDA for 2-way 100% Silicone Cleartract Catheter.
| Device ID | K222118 |
| 510k Number | K222118 |
| Device Name: | 2-Way 100% Silicone Cleartract Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | SILQ Technologies, Corp. 323 Sunny Isles Blvd., 7th Floor Sunny Isles Beach, FL 33160 |
| Contact | D. Verne Sharma |
| Correspondent | Aaron Rogers Pathway LLC 8779 Cottonwood Ave, Suite 105 Santee, CA 92071 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2022-07-18 |
| Decision Date | 2022-12-01 |