The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Polysafe Ccs Trifix Endocardial Pacing Lead Sv-107.
| Device ID | K853446 |
| 510k Number | K853446 |
| Device Name: | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Robert S Springer |
| Correspondent | Robert S Springer 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 | 1985-08-16 |
| Decision Date | 1986-01-13 |