The following data is part of a premarket notification filed by Chirana T. Injecta with the FDA for Chiravac Blood Collection Needles.
| Device ID | K201009 |
| 510k Number | K201009 |
| Device Name: | CHIRAVAC Blood Collection Needles |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | CHIRANA T. Injecta Nàm. Dr. Schweitzera 194 Starà Turà, SK 916 01 |
| Contact | Zdenka Klbeckova |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2021-07-21 |