The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Checkvalve Administration Set, Model 21-7090.
| Device ID | K000942 |
| 510k Number | K000942 |
| Device Name: | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 |
| Classification | Set, Administration, Intravascular |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586034507 | K000942 | 000 |
| 30610586024171 | K000942 | 000 |
| 30610586024164 | K000942 | 000 |
| 30610586022368 | K000942 | 000 |