The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Venacure Procedure Kit.
| Device ID | K102796 |
| 510k Number | K102796 |
| Device Name: | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2010-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787514030100 | K102796 | 000 |
| H787514020060 | K102796 | 000 |
| H787514020070 | K102796 | 000 |
| H787514020080 | K102796 | 000 |
| H787514030010 | K102796 | 000 |
| H787514030020 | K102796 | 000 |
| H787514030050 | K102796 | 000 |
| H787514030070 | K102796 | 000 |
| H787514030080 | K102796 | 000 |
| H787514030090 | K102796 | 000 |
| H787514020050 | K102796 | 000 |