The following data is part of a premarket notification filed by Clinico with the FDA for Taky-spike Plus.
| Device ID | K974198 |
| 510k Number | K974198 |
| Device Name: | TAKY-SPIKE PLUS |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CLINICO 5 ROBERT-KOCH-STRASSE Bad Hersfeld, DE D-36251 |
| Contact | Reinhard Hopf |
| Correspondent | Reinhard Hopf CLINICO 5 ROBERT-KOCH-STRASSE Bad Hersfeld, DE D-36251 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1997-12-22 |