The following data is part of a premarket notification filed by Medinol, Ltd. with the FDA for Gallant Ptca Dilatation Catheter.
| Device ID | K173581 |
| 510k Number | K173581 |
| Device Name: | Gallant PTCA Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Medinol, Ltd. Kiryat Atidim, Bldg. 8 Tel Aviv, IL 6158101 |
| Contact | Marina Tikhonov Demishtein |
| Correspondent | H. Semih Oktay CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, MD 21228 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290107014557 | K173581 | 000 |
| 07290107014540 | K173581 | 000 |
| 07290107014533 | K173581 | 000 |
| 07290107014526 | K173581 | 000 |
| 07290107014519 | K173581 | 000 |
| 07290107014502 | K173581 | 000 |
| 07290107014496 | K173581 | 000 |
| 07290107014489 | K173581 | 000 |