The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire Asahi Gladius Mongo 14, Asahi Gladius Mongo 14 Es.
| Device ID | K180784 |
| 510k Number | K180784 |
| Device Name: | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, MD 21037 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-26 |
| Decision Date | 2018-07-18 |
| Summary: | summary |