The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Hemocath Repair Kit.
| Device ID | K840424 |
| 510k Number | K840424 |
| Device Name: | HEMOCATH REPAIR KIT |
| Classification | Accessories, A-v Shunt |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNZ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009933 | K840424 | 000 |
| 10884521056121 | K840424 | 000 |
| 10884521009929 | K840424 | 000 |