The following data is part of a premarket notification filed by Filmecc Co., Ltd. with the FDA for Vassallo Gt 018 Floppy.
| Device ID | K213949 |
| 510k Number | K213949 |
| Device Name: | VASSALLO GT 018 Floppy |
| Classification | Wire, Guide, Catheter |
| Applicant | Filmecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, JP 463-0024 |
| Contact | Toshiya Osawa |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 200 Annapolis, MD 21401 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582105830134 | K213949 | 000 |
| 14582105830124 | K213949 | 000 |