The following data is part of a premarket notification filed by Allwin Medical Devices, Inc with the FDA for Allflex Ureteral Catheters, Krait Ureteral Catheters.
| Device ID | K220730 |
| 510k Number | K220730 |
| Device Name: | AllFlex Ureteral Catheters, Krait Ureteral Catheters |
| Classification | Catheter, Urological |
| Applicant | Allwin Medical Devices, Inc 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Contact | Digish Mehta |
| Correspondent | Digish Mehta Allwin Medical Devices, Inc 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812261016020 | K220730 | 000 |
| 10812261013319 | K220730 | 000 |
| 10819374024966 | K220730 | 000 |
| 10819374024379 | K220730 | 000 |
| 10819374023174 | K220730 | 000 |
| 10819374022405 | K220730 | 000 |
| 10819374022382 | K220730 | 000 |
| 10819374020418 | K220730 | 000 |
| 10819374020401 | K220730 | 000 |