The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for High Pressure Tubing.
| Device ID | K941978 |
| 510k Number | K941978 |
| Device Name: | HIGH PRESSURE TUBING |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Contact | Frederik A Gustafson |
| Correspondent | Frederik A Gustafson ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-14 |
| Decision Date | 1994-12-13 |