The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Teflon Cannula.
| Device ID | K822776 |
| 510k Number | K822776 |
| Device Name: | TEFLON CANNULA |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CARDIAC PACEMAKERS, INC. MN |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-11-03 |