The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Clave Needle-less Connector Open Extension Set.
| Device ID | K941190 |
| 510k Number | K941190 |
| Device Name: | CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1995-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619025097 | K941190 | 000 |
| 10840619056787 | K941190 | 000 |
| 10840619034471 | K941190 | 000 |