The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteq Angiographic Catheter.
| Device ID | K102633 |
| 510k Number | K102633 |
| Device Name: | BIOTEQ ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOTEQUE CORP. 2904 N BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich BIOTEQUE CORP. 2904 N BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-13 |
| Decision Date | 2011-09-09 |
| Summary: | summary |