The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Vortex Radial Spray Catheter.
| Device ID | K201183 |
| 510k Number | K201183 |
| Device Name: | Vortex Radial Spray Catheter |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CSA Medical, Inc. 91 Hartwell Ave Lexington, MA 02421 |
| Contact | Heather V Nigro |
| Correspondent | Heather V Nigro CSA Medical, Inc. 91 Hartwell Ave Lexington, MA 02421 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995199231 | K201183 | 000 |