The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Duramax Chronic Hemodialysis Catheter And Procedure Kit.
| Device ID | K101843 |
| 510k Number | K101843 |
| Device Name: | DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | ANGIODYNAMICS, INC. 14 PLAZA DRIVE Latham, NY 12110 |
| Contact | David A Greer |
| Correspondent | David A Greer ANGIODYNAMICS, INC. 14 PLAZA DRIVE Latham, NY 12110 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787103028205 | K101843 | 000 |
| H787103029041 | K101843 | 000 |
| H787103029035 | K101843 | 000 |
| H787103029025 | K101843 | 000 |
| H787103029015 | K101843 | 000 |
| H787103028245 | K101843 | 000 |
| H787103028235 | K101843 | 000 |
| H787103028225 | K101843 | 000 |
| H787103028215 | K101843 | 000 |
| H787103028175 | K101843 | 000 |
| H787103028165 | K101843 | 000 |
| H787103028025 | K101843 | 000 |
| H787103029055 | K101843 | 000 |
| H787103029065 | K101843 | 000 |
| H787103029075 | K101843 | 000 |
| H787103028191 | K101843 | 000 |
| H787103028185 | K101843 | 000 |
| H787103028095 | K101843 | 000 |
| H787103028085 | K101843 | 000 |
| H787103028075 | K101843 | 000 |
| H787103028061 | K101843 | 000 |
| H787103028041 | K101843 | 000 |
| H787103028031 | K101843 | 000 |
| H787103028055 | K101843 | 000 |
| H787103029095 | K101843 | 000 |
| H787103029085 | K101843 | 000 |
| H787103028015 | K101843 | 000 |