The following data is part of a premarket notification filed by Shanghai Microport Medical (group) Co., Ltd with the FDA for Foxtrot Nc Ptca Balloon Catheter.
| Device ID | K143160 |
| 510k Number | K143160 |
| Device Name: | FOXTROT NC PTCA Balloon Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD 501 NEWTON ROAD Shanghai, CN 201203 |
| Contact | Jingwen Li |
| Correspondent | Erika Huffman NAMSA 4050 OLSON MEMORIAL HIGHWAY, Minneapolis, MN 55422 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-03-05 |
| Summary: | summary |