The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc., Percutaneous Introducer And Venacureevlt Procedure Kit.
| Device ID | K100199 |
| 510k Number | K100199 |
| Device Name: | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT 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 | 2010-01-22 |
| Decision Date | 2010-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787114033015 | K100199 | 000 |
| H787114033025 | K100199 | 000 |