The following data is part of a premarket notification filed by Maclin Power Inc. with the FDA for Maclin Power Intravascular Administration Set.
| Device ID | K121511 |
| 510k Number | K121511 |
| Device Name: | MACLIN POWER INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MACLIN POWER INC. VIA MARZIA, 9 Abano Terme, Pd, IT 35031 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson MACLIN POWER INC. VIA MARZIA, 9 Abano Terme, Pd, IT 35031 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810083350875 | K121511 | 000 |
| 00810083350844 | K121511 | 000 |
| 00810083350370 | K121511 | 000 |
| 00810083350257 | K121511 | 000 |
| 00810083350400 | K121511 | 000 |
| 00810083350394 | K121511 | 000 |
| 00810083350387 | K121511 | 000 |
| 00810083350417 | K121511 | 000 |
| 00810083350431 | K121511 | 000 |