The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Thermodilution Catheter Intro. Kit.
| Device ID | K800619 |
| 510k Number | K800619 |
| Device Name: | THERMODILUTION CATHETER INTRO. KIT |
| Classification | Introducer, Catheter |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-18 |
| Decision Date | 1980-04-24 |