The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteque A.v. Fistula Needle Set With Safety Flex.
| Device ID | K032292 |
| 510k Number | K032292 |
| Device Name: | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2004-03-22 |
| Summary: | summary |