The following data is part of a premarket notification filed by Merit Medical Singapore Pte. Ltd. with the FDA for Merit Radialflo Arterial Catheter.
| Device ID | K182538 |
| 510k Number | K182538 |
| Device Name: | Merit RadialFlo Arterial Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Merit Medical Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore, SG 768926 |
| Contact | Xing Ting Seow |
| Correspondent | Xing Ting Seow Merit Medical Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore, SG 768926 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-14 |
| Decision Date | 2019-01-16 |
| Summary: | summary |