The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models Hvt100, Adt1001, Adt1002.
| Device ID | K033424 |
| 510k Number | K033424 |
| Device Name: | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-12-11 |
| Summary: | summary |