The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Lopez Valve Tm Ii.
| Device ID | K915171 |
| 510k Number | K915171 |
| Device Name: | LOPEZ VALVE TM II |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Araceli C Francher |
| Correspondent | Araceli C Francher ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741113908 | K915171 | 000 |
| 10840619046177 | K915171 | 000 |
| 10887709037134 | K915171 | 000 |
| 10887709056951 | K915171 | 000 |
| 10887709078533 | K915171 | 000 |
| 10887709078540 | K915171 | 000 |
| 10887709098265 | K915171 | 000 |
| 10887709029627 | K915171 | 000 |
| 10887709037127 | K915171 | 000 |
| 10801741052368 | K915171 | 000 |
| 10887709098258 | K915171 | 000 |