The following data is part of a premarket notification filed by Lifetech Scientific (shenzhen) Co., Ltd. with the FDA for Fustar Steerable Introducers.
| Device ID | K100184 |
| 510k Number | K100184 |
| Device Name: | FUSTAR STEERABLE INTRODUCERS |
| Classification | Catheter, Percutaneous |
| Applicant | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. # 19, LN 999, ZHONGSHAN RD S2 SUITE 5D Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. # 19, LN 999, ZHONGSHAN RD S2 SUITE 5D Shanghai, CN 200030 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-21 |
| Decision Date | 2011-02-14 |
| Summary: | summary |