The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Diatek Connector Assembly Replacement Kit (cark).
| Device ID | K020430 |
| 510k Number | K020430 |
| Device Name: | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) |
| Classification | Kit, Repair, Catheter, Hemodialysis |
| Applicant | DIATEK, INC. 101 N. CHESTNUT ST. #300 Winston-salem, NC 27101 |
| Contact | Jon Wilson |
| Correspondent | Jon Wilson DIATEK, INC. 101 N. CHESTNUT ST. #300 Winston-salem, NC 27101 |
| Product Code | NFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-08 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801902096842 | K020430 | 000 |
| 10801902031591 | K020430 | 000 |
| 10801902031584 | K020430 | 000 |
| 10801902031577 | K020430 | 000 |
| 10801902031560 | K020430 | 000 |
| 50801902096840 | K020430 | 000 |
| 50801902096833 | K020430 | 000 |
| 10801902197426 | K020430 | 000 |
| 30801902195235 | K020430 | 000 |
| 30801902196720 | K020430 | 000 |
| 30801902195334 | K020430 | 000 |
| 10801902197488 | K020430 | 000 |
| 30801902197468 | K020430 | 000 |
| 10801902197402 | K020430 | 000 |
| 30801902197352 | K020430 | 000 |
| 10801902033403 | K020430 | 000 |
| 30801902049309 | K020430 | 000 |
| 10801902049312 | K020430 | 000 |
| 30801902096839 | K020430 | 000 |
| 10801902096828 | K020430 | 000 |
| 30801902096815 | K020430 | 000 |
| 30801902096808 | K020430 | 000 |
| 10801902096798 | K020430 | 000 |
| 10801902096156 | K020430 | 000 |
| 10801902096149 | K020430 | 000 |
| 10801902096132 | K020430 | 000 |
| 10801902096125 | K020430 | 000 |
| 30801902096112 | K020430 | 000 |
| 30801902082702 | K020430 | 000 |
| 30801902082696 | K020430 | 000 |
| 10801902049336 | K020430 | 000 |
| 10801902049329 | K020430 | 000 |
| 10801902197372 | K020430 | 000 |