The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Polysafe Implant. Pacing Leads W/tined Fixa. Tip.
| Device ID | K883016 |
| 510k Number | K883016 |
| Device Name: | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP |
| Classification | Permanent Pacemaker Electrode |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Scott J Mindrebo |
| Correspondent | Scott J Mindrebo CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-09-16 |