The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc., Micro Access Kits.
| Device ID | K051655 |
| 510k Number | K051655 |
| Device Name: | ANGIODYNAMICS, INC., MICRO ACCESS KITS |
| Classification | Cannula, Catheter |
| 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 | DQR |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DRC |
| Subsequent Product Code | DYB |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-21 |
| Decision Date | 2005-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787065970175 | K051655 | 000 |
| H787065970035 | K051655 | 000 |
| H787065970025 | K051655 | 000 |
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