The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Tb Series Bipolar Pacing Leads.
| Device ID | K861403 |
| 510k Number | K861403 |
| Device Name: | TB SERIES BIPOLAR PACING LEADS |
| Classification | Electrode, Pacemaker, Temporary |
| 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 | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672001872 | K861403 | 000 |
| 00836559009764 | K861403 | 000 |
| 00836559009757 | K861403 | 000 |
| 00836559009740 | K861403 | 000 |
| 00836559009733 | K861403 | 000 |
| 00836559009726 | K861403 | 000 |
| 00836559009719 | K861403 | 000 |
| 00836559009702 | K861403 | 000 |
| 00836559009696 | K861403 | 000 |
| 00836559009078 | K861403 | 000 |
| 00836559009061 | K861403 | 000 |
| 00836559009054 | K861403 | 000 |
| 00836559009047 | K861403 | 000 |
| 00836559009030 | K861403 | 000 |
| 00836559009023 | K861403 | 000 |
| 00836559007265 | K861403 | 000 |
| 00836559009771 | K861403 | 000 |
| 00836559009788 | K861403 | 000 |
| 00885672001865 | K861403 | 000 |
| 00836559009924 | K861403 | 000 |
| 00836559009917 | K861403 | 000 |
| 00836559009900 | K861403 | 000 |
| 00836559009894 | K861403 | 000 |
| 00836559009887 | K861403 | 000 |
| 00836559009870 | K861403 | 000 |
| 00836559009863 | K861403 | 000 |
| 00836559009856 | K861403 | 000 |
| 00836559009849 | K861403 | 000 |
| 00836559009832 | K861403 | 000 |
| 00836559009825 | K861403 | 000 |
| 00836559009818 | K861403 | 000 |
| 00836559009801 | K861403 | 000 |
| 00836559009795 | K861403 | 000 |
| 00836559007258 | K861403 | 000 |