The following data is part of a premarket notification filed by Thinkmed Medical Technology Co., Ltd. with the FDA for Thinkmed Intermittent Catheter With/without Hydrophilic Coating.
| Device ID | K142767 |
| 510k Number | K142767 |
| Device Name: | ThinkMed Intermittent Catheter With/without Hydrophilic Coating |
| Classification | Catheter, Urethral |
| Applicant | ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan, CN 215341 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan, CN 215341 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-25 |
| Decision Date | 2015-02-03 |
| Summary: | summary |