The following data is part of a premarket notification filed by Custom Assemblies, Inc. with the FDA for Intravascular Administration Set.
| Device ID | K993463 |
| 510k Number | K993463 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CUSTOM ASSEMBLIES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden CUSTOM ASSEMBLIES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 2000-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H65857018821 | K993463 | 000 |
| 00815849023406 | K993463 | 000 |
| 00815849024717 | K993463 | 000 |
| 40193489246699 | K993463 | 000 |
| 00815849023192 | K993463 | 000 |
| 00815849023277 | K993463 | 000 |
| 10193489585063 | K993463 | 000 |
| 10889942379057 | K993463 | 000 |
| 10889942699353 | K993463 | 000 |
| 00815849023369 | K993463 | 000 |