The following data is part of a premarket notification filed by Chengdu Daxan Innovative Medical Tech. Co., Ltd with the FDA for Pvc Hydrophilic Urethral Catheter.
| Device ID | K212567 |
| 510k Number | K212567 |
| Device Name: | PVC Hydrophilic Urethral Catheter |
| Classification | Catheter, Straight |
| Applicant | Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu, CN 611135 |
| Contact | Kevin Huang |
| Correspondent | Kevin Huang Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu, CN 611135 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 86971976787465 | K212567 | 000 |
| 86971976786901 | K212567 | 000 |
| 06971976782419 | K212567 | 000 |
| 86971976782385 | K212567 | 000 |
| 86971976782330 | K212567 | 000 |
| 86971976786871 | K212567 | 000 |
| 86971976786864 | K212567 | 000 |
| 86971976786857 | K212567 | 000 |
| 86971976786819 | K212567 | 000 |
| 86971976786796 | K212567 | 000 |
| 86971976786789 | K212567 | 000 |
| 86971976786758 | K212567 | 000 |
| 86971976786727 | K212567 | 000 |
| 86971976786680 | K212567 | 000 |
| 86971976786666 | K212567 | 000 |
| 86971976786918 | K212567 | 000 |
| 86971976786987 | K212567 | 000 |
| 86971976787618 | K212567 | 000 |
| 86971976787571 | K212567 | 000 |
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| 86971976787540 | K212567 | 000 |
| 86971976787519 | K212567 | 000 |
| 86971976787427 | K212567 | 000 |
| 86971976787410 | K212567 | 000 |
| 86971976787397 | K212567 | 000 |
| 86971976787366 | K212567 | 000 |
| 86971976787359 | K212567 | 000 |
| 86971976787298 | K212567 | 000 |
| 86971976787267 | K212567 | 000 |
| 86971976787205 | K212567 | 000 |
| 86971976786994 | K212567 | 000 |
| 86971976786635 | K212567 | 000 |