The following data is part of a premarket notification filed by Webster Laboratories, Inc. with the FDA for Cardiovascular, Thermodilution, Flow, Coronary Sin.
| Device ID | K853383 |
| 510k Number | K853383 |
| Device Name: | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN |
| Classification | Catheter, Flow Directed |
| Applicant | WEBSTER LABORATORIES, INC. 5114 COMMERCE DR. Baldwin Park, CA 91706 |
| Contact | Wilton W Webster |
| Correspondent | Wilton W Webster WEBSTER LABORATORIES, INC. 5114 COMMERCE DR. Baldwin Park, CA 91706 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-12-03 |