The following data is part of a premarket notification filed by Elecath with the FDA for Pacemate Flow Directed Thermal Dilution Catheter.
| Device ID | K900317 |
| 510k Number | K900317 |
| Device Name: | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER |
| Classification | Probe, Thermodilution |
| Applicant | ELECATH 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Contact | Lorraine Montemurro |
| Correspondent | Lorraine Montemurro ELECATH 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-06-22 |