The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Titan Driver 60cc, 30 Minute Administration Set.
| Device ID | K953028 |
| 510k Number | K953028 |
| Device Name: | TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-29 |
| Decision Date | 1995-09-28 |