The following data is part of a premarket notification filed by Triton Medical, Llc with the FDA for Triton Meidcal Tmed Iv-set.
| Device ID | K073444 |
| 510k Number | K073444 |
| Device Name: | TRITON MEIDCAL TMED IV-SET |
| Classification | Set, Administration, Intravascular |
| Applicant | TRITON MEDICAL, LLC 1705 S. CAPITAL OF TEXAS HWY Austin, TX 78746 |
| Contact | Ian P Gordon |
| Correspondent | Ian P Gordon TRITON MEDICAL, LLC 1705 S. CAPITAL OF TEXAS HWY Austin, TX 78746 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-07 |
| Decision Date | 2008-08-18 |
| Summary: | summary |