The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Duraflow 2 Chronic Hemodialysis Catheter And Procedure Kit.
| Device ID | K110936 |
| 510k Number | K110936 |
| Device Name: | DURAFLOW 2 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 | 2011-04-04 |
| Decision Date | 2011-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450794975 | K110936 | 000 |
| 10884450795009 | K110936 | 000 |
| 10884450786113 | K110936 | 000 |
| 00884450795101 | K110936 | 000 |
| H787103012015 | K110936 | 000 |
| H787103012025 | K110936 | 000 |
| H787103012035 | K110936 | 000 |
| H787103012045 | K110936 | 000 |
| H787103012055 | K110936 | 000 |
| 10884450795054 | K110936 | 000 |
| 10884450795061 | K110936 | 000 |
| 10884450786120 | K110936 | 000 |
| 00884450794999 | K110936 | 000 |
| 00884450795040 | K110936 | 000 |
| 00884450794951 | K110936 | 000 |
| 00884450794968 | K110936 | 000 |
| 00884450795088 | K110936 | 000 |
| 10884450795153 | K110936 | 000 |
| 00884450795026 | K110936 | 000 |
| 00884450795095 | K110936 | 000 |
| H787103012115 | K110936 | 000 |
| H787103012125 | K110936 | 000 |
| H787103017015 | K110936 | 000 |
| H787103017025 | K110936 | 000 |
| H787103017035 | K110936 | 000 |
| H787103017045 | K110936 | 000 |
| H787103017055 | K110936 | 000 |
| H787103017115 | K110936 | 000 |
| H787103017135 | K110936 | 000 |
| H787103017145 | K110936 | 000 |
| H787103012245 | K110936 | 000 |
| H787103012235 | K110936 | 000 |
| H787103012225 | K110936 | 000 |
| H787103012145 | K110936 | 000 |
| H787103012155 | K110936 | 000 |
| H787103012165 | K110936 | 000 |
| H787103012175 | K110936 | 000 |
| H787103012185 | K110936 | 000 |
| H787103012195 | K110936 | 000 |
| H787103012205 | K110936 | 000 |
| H787103012215 | K110936 | 000 |
| H787103017155 | K110936 | 000 |