The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Angio Flow Thermodilution Catheter, Model Af-cath-01; Angioflow Meter, Models Hq100 And Hq101.
| Device ID | K010253 |
| 510k Number | K010253 |
| Device Name: | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 |
| Classification | Catheter, Flow Directed |
| Applicant | TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-26 |
| Decision Date | 2002-03-19 |