The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Oscor Medical Fix Screw Pacing Lead/peelable Cath.
| Device ID | K861493 |
| 510k Number | K861493 |
| Device Name: | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Contact | De Graad |
| Correspondent | De Graad OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-22 |
| Decision Date | 1986-08-28 |