The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for 4f Sterile Balloon-less, Catheter 913-28.
| Device ID | K791026 |
| 510k Number | K791026 |
| Device Name: | 4F STERILE BALLOON-LESS, CATHETER 913-28 |
| Classification | Probe, Thermodilution |
| Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-04 |
| Decision Date | 1979-06-22 |