The following data is part of a premarket notification filed by Synaptic Medical Limited with the FDA for Steerable Intracardiac Catheter Introducer Kit And Transseptal Needle.
| Device ID | K151936 |
| 510k Number | K151936 |
| Device Name: | Steerable Intracardiac Catheter Introducer Kit And Transseptal Needle |
| Classification | Introducer, Catheter |
| Applicant | SYNAPTIC MEDICAL LIMITED BUILDING C, 100 KECHUANG 6TH STREET, BEIJING ECO-TECH DEVELOPMENT AREA Beijing, CN 101111 |
| Contact | Yang Tiecheng |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2015-12-04 |
| Summary: | summary |