The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Tube, Leatherman/imbruce.
| Device ID | K781665 |
| 510k Number | K781665 |
| Device Name: | TUBE, LEATHERMAN/IMBRUCE |
| Classification | Catheter, Balloon Type |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBA |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-28 |
| Decision Date | 1978-12-15 |