The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Sheath Introducer.
| Device ID | K150932 |
| 510k Number | K150932 |
| Device Name: | Sheath Introducer |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | BIOTEQUE CORP. 5 F-6, NO. 23, SEC. 1 CHANG-AN E. ROAD Taipei, TW 104 |
| Contact | Simon Lin |
| Correspondent | Stella Hsu BIOTEQUE CORP. 5 F-6, NO. 23, SEC. 1 CHANG-AN E. ROAD Taipei, TW 104 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2016-07-22 |
| Summary: | summary |