The following data is part of a premarket notification filed by Accurate Medical Therapeutics Ltd. with the FDA for Drakon And Sequre Microcatheters.
| Device ID | K202797 |
| 510k Number | K202797 |
| Device Name: | Drakon And Sequre Microcatheters |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Accurate Medical Therapeutics Ltd. 19 Eli Hurvitz Street Rehovot, IL 7608802 |
| Contact | Osnat Harbater |
| Correspondent | Osnat Harbater Accurate Medical Therapeutics Ltd. 19 Eli Hurvitz Street Rehovot, IL 7608802 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-23 |
| Decision Date | 2020-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017268859 | K202797 | 000 |
| 07290017268323 | K202797 | 000 |
| 07290017268330 | K202797 | 000 |
| 07290017268347 | K202797 | 000 |
| 07290017268354 | K202797 | 000 |
| 07290017268385 | K202797 | 000 |
| 07290017268392 | K202797 | 000 |
| 07290017268408 | K202797 | 000 |
| 07290017268804 | K202797 | 000 |
| 07290017268811 | K202797 | 000 |
| 07290017268828 | K202797 | 000 |
| 07290017268866 | K202797 | 000 |
| 07290017268873 | K202797 | 000 |
| 07290017268880 | K202797 | 000 |
| 07290017268309 | K202797 | 000 |
| 07290017268835 | K202797 | 000 |
| 07290017268842 | K202797 | 000 |
| 07290017268316 | K202797 | 000 |