The following data is part of a premarket notification filed by Alba Critical Care Ltd with the FDA for Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom.
| Device ID | K993245 |
| 510k Number | K993245 |
| Device Name: | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM |
| Classification | Catheter, Flow Directed |
| Applicant | ALBA CRITICAL CARE LTD PHOENIX CRESCENT STRATHCLYDE BUSINESS PARK Bellshill, Lanarkshire, GB Ml4 3nj |
| Contact | Ted Vander Wiede |
| Correspondent | Ted Vander Wiede ALBA CRITICAL CARE LTD PHOENIX CRESCENT STRATHCLYDE BUSINESS PARK Bellshill, Lanarkshire, GB Ml4 3nj |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 1999-10-28 |
| Summary: | summary |