The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Heparin Coated Thermodilution Catheters.
| Device ID | K840824 |
| 510k Number | K840824 |
| Device Name: | HEPARIN COATED THERMODILUTION CATHETERS |
| Classification | Probe, Thermodilution |
| Applicant | GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | None None |
| Correspondent | None None GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-05-23 |