The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Interim Av Shaped Temporary Pacing Catheter Model Int-av610.
| Device ID | K971775 |
| 510k Number | K971775 |
| Device Name: | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-13 |
| Decision Date | 1997-12-29 |
| Summary: | summary |