The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Heparin Coated Thermodilution Catheter.
| Device ID | K821235 |
| 510k Number | K821235 |
| Device Name: | HEPARIN COATED THERMODILUTION CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-28 |
| Decision Date | 1982-05-18 |