The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Quick Prime Lines, #'s Bpl-12, Bpl-48 &.
| Device ID | K802378 |
| 510k Number | K802378 |
| Device Name: | QUICK PRIME LINES, #'S BPL-12, BPL-48 & |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-30 |
| Decision Date | 1980-10-10 |