The following data is part of a premarket notification filed by Delta Med Spa with the FDA for Intravascular Administration Set.
| Device ID | K140175 |
| 510k Number | K140175 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DELTA MED SPA PIAZZA ALBANIA, N'10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray DELTA MED SPA PIAZZA ALBANIA, N'10 Rome, IT 00153 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-23 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58032248369127 | K140175 | 000 |
| 58032248369028 | K140175 | 000 |
| 58032248368526 | K140175 | 000 |
| 58032248368168 | K140175 | 000 |