The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Dye Management System.
| Device ID | K941254 |
| 510k Number | K941254 |
| Device Name: | DYE MANAGEMENT SYSTEM |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Contact | Frederick A Gustafson |
| Correspondent | Frederick A Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619063259 | K941254 | 000 |