The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Corsair Armet.
| Device ID | K161362 |
| 510k Number | K161362 |
| Device Name: | ASAHI Corsair Armet |
| Classification | Catheter, Percutaneous |
| Applicant | Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-Ku Nagoya, JP 463-0024 |
| Contact | Carroll Councilman |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-06-14 |
| Summary: | summary |