The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Infus. Sets-9120-50 Cm & 9121-100 Cm,ext.
| Device ID | K822775 |
| 510k Number | K822775 |
| Device Name: | INFUS. SETS-9120-50 CM & 9121-100 CM,EXT |
| Classification | Set, Administration, Intravascular |
| Applicant | CARDIAC PACEMAKERS, INC. MN |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-11-03 |