The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Stiff Stylets.
| Device ID | K802076 |
| 510k Number | K802076 |
| Device Name: | STIFF STYLETS |
| Classification | Stylet, Catheter |
| Applicant | CARDIAC PACEMAKERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-28 |
| Decision Date | 1980-09-26 |