The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Venacure 1470 Laser.
| Device ID | K110225 |
| 510k Number | K110225 |
| Device Name: | ANGIODYNAMICS, INC. VENACURE 1470 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ANGIODYNAMICS, INC. 14 PLAZA DRIVE Latham, NY 12110 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 14 PLAZA DRIVE Latham, NY 12110 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684015134 | K110225 | 000 |