The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Solero Mta Cart, Solero Mta System, Solero Microwave Tissue Ablation Applicator (14cm), , Solero Microwave Tissue Ablation Applicator (19cm), Solero Microwave Tissue Ablation Applicator (29cm).
| Device ID | K182250 |
| 510k Number | K182250 |
| Device Name: | Solero MTA Cart, Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), , Solero Microwave Tissue Ablation Applicator (19cm), Solero Microwave Tissue Ablation Applicator (29cm) |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 |
| Contact | Kasey Newcomb |
| Correspondent | Kasey Newcomb AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2019-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787127401380 | K182250 | 000 |