The following data is part of a premarket notification filed by Vascor Medical Corp. with the FDA for Vascoscrew 6/60 And Vascoscrew 8/60.
| Device ID | K914121 |
| 510k Number | K914121 |
| Device Name: | VASCOSCREW 6/60 AND VASCOSCREW 8/60 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | VASCOR MEDICAL CORP. P.O. BOX 148 Tarpon Springs, FL 34688 -0148 |
| Contact | Audrey Maccia |
| Correspondent | Audrey Maccia VASCOR MEDICAL CORP. P.O. BOX 148 Tarpon Springs, FL 34688 -0148 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-13 |
| Decision Date | 1993-08-24 |