The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. More-flow Hemodialysis Catheter And Procedure Kit.
| Device ID | K040402 |
| 510k Number | K040402 |
| Device Name: | ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT |
| Classification | Catheter, Hemodialysis, Implanted |
| 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 | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787103036125 | K040402 | 000 |
| H787103035075 | K040402 | 000 |
| H787103035065 | K040402 | 000 |
| H787103035055 | K040402 | 000 |
| H787103035045 | K040402 | 000 |
| H787103035035 | K040402 | 000 |
| H787103035025 | K040402 | 000 |
| H787103035015 | K040402 | 000 |
| 00884450803684 | K040402 | 000 |
| 00884450803677 | K040402 | 000 |
| 00884450804117 | K040402 | 000 |
| 00884450804162 | K040402 | 000 |
| 00884450804131 | K040402 | 000 |
| 00884450804124 | K040402 | 000 |
| H787103035085 | K040402 | 000 |
| H787103035095 | K040402 | 000 |
| H787103035105 | K040402 | 000 |
| H787103036115 | K040402 | 000 |
| H787103036105 | K040402 | 000 |
| H787103036095 | K040402 | 000 |
| H787103036085 | K040402 | 000 |
| H787103036075 | K040402 | 000 |
| H787103036065 | K040402 | 000 |
| H787103036055 | K040402 | 000 |
| H787103036045 | K040402 | 000 |
| H787103036035 | K040402 | 000 |
| H787103036025 | K040402 | 000 |
| H787103036015 | K040402 | 000 |
| H787103035125 | K040402 | 000 |
| H787103035115 | K040402 | 000 |
| 00884450804148 | K040402 | 000 |