The following data is part of a premarket notification filed by Biosensors International Pte Ltd with the FDA for Silicone Foley Catheter.
| Device ID | K182463 |
| 510k Number | K182463 |
| Device Name: | Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Biosensors International Pte Ltd 36 Jalan Tukang Singapore, SG 619266 |
| Contact | Lor Yen Yin |
| Correspondent | Jane Chen Biosensors International Pte Ltd 36 Jalan Tukang Singapore, SG 619266 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-11-06 |