The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Amsure Hydrophilic Intermittent Catheter.
| Device ID | K181445 |
| 510k Number | K181445 |
| Device Name: | AMSure Hydrophilic Intermittent Catheter |
| Classification | Catheter, Straight |
| Applicant | Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Contact | Zoe Wu |
| Correspondent | Zoe Wu Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-10-01 |
| Summary: | summary |