The following data is part of a premarket notification filed by Deltec, Inc. with the FDA for Cadd High-volume Administration Sets With Flowstop.
| Device ID | K031361 |
| 510k Number | K031361 |
| Device Name: | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP |
| Classification | Set, Administration, Intravascular |
| Applicant | DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517191770 | K031361 | 000 |
| 35019517191732 | K031361 | 000 |
| 35019517191718 | K031361 | 000 |
| 35019517191701 | K031361 | 000 |
| 35019517161971 | K031361 | 000 |
| 35019517161964 | K031361 | 000 |
| 35019517161957 | K031361 | 000 |