The following data is part of a premarket notification filed by Us Infusion Dba Truecare Biomedix with the FDA for Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set.
| Device ID | K111351 |
| 510k Number | K111351 |
| Device Name: | TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | US INFUSION DBA TRUECARE BIOMEDIX 2003 NW 79TH AVE. Miami, FL 33122 |
| Contact | Aaron Compton |
| Correspondent | Aaron Compton US INFUSION DBA TRUECARE BIOMEDIX 2003 NW 79TH AVE. Miami, FL 33122 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850789007301 | K111351 | 000 |
| 20850789007745 | K111351 | 000 |
| 20850789007752 | K111351 | 000 |
| 20850789007660 | K111351 | 000 |
| 00860006128029 | K111351 | 000 |
| 00850789007413 | K111351 | 000 |
| 00850789007390 | K111351 | 000 |
| 00850789007406 | K111351 | 000 |
| 10850789007373 | K111351 | 000 |
| 10850789007380 | K111351 | 000 |
| 20850789007370 | K111351 | 000 |
| 20850789007387 | K111351 | 000 |
| 10850789007281 | K111351 | 000 |
| 10850789007298 | K111351 | 000 |
| 10850789007304 | K111351 | 000 |
| 20850789007288 | K111351 | 000 |
| 20850789007295 | K111351 | 000 |
| 20850789007813 | K111351 | 000 |