The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Pharmacia Deltec Extension Set With Anti-siphon Valve.
| Device ID | K942046 |
| 510k Number | K942046 |
| Device Name: | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short PHARMACIA 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 | 1994-04-28 |
| Decision Date | 1994-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517184208 | K942046 | 000 |
| 30610586022719 | K942046 | 000 |
| 30610586020456 | K942046 | 000 |
| 30610586020449 | K942046 | 000 |
| 30610586020432 | K942046 | 000 |
| 30610586020319 | K942046 | 000 |
| 30610586020302 | K942046 | 000 |
| 30610586020296 | K942046 | 000 |
| 30610586020227 | K942046 | 000 |