Oscor Medical Corp.
Washington, DC, US
Oscor Medical Corp. appears in FDA device records in Washington, DC. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Oscor Medical Corp. between 1985 and 1997. The busiest year on record is 1991, with 9. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 6 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 2 |
| 1991 | 9 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | DTB | Substantially Equivalent - Subject to Tracking & PMS | |
| K925168 | MISCELLANEOUS PACING LEAD | DTD | Substantially Equivalent | |
| K923621 | EXTERNAL DEMAND PACEMAKER | DTE | Substantially Equivalent | |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | DTB | Substantially Equivalent | |
| K915008 | PERMANENT PACING PAD, MODIFICATION | DTB | Substantially Equivalent | |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | DTB | Substantially Equivalent | |
| K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION | DTB | Substantially Equivalent | |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | DTB | Substantially Equivalent | |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | DTB | Substantially Equivalent | |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | DTB | Substantially Equivalent | |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | DTB | Substantially Equivalent | |
| K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION | DTB | Substantially Equivalent | |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | DTB | Substantially Equivalent | |
| K905300 | PERMANENT PACING LEAD | DTB | Substantially Equivalent | |
| K905182 | OSCOR MEDICAL CORP. PERMANENT PACING PAD | DTB | Substantially Equivalent | |
| K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | LDF | Substantially Equivalent | |
| K890277 | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT | DYB | Substantially Equivalent | |
| K882462 | PERMANENT PACING LEAD MODEL RXBJ SERIES | DTB | Substantially Equivalent | |
| K882345 | PERMANENT PACING LEADS PYBJ SERIES | DTB | Substantially Equivalent | |
| K882327 | PACER SENSING ANALYZER (PSA 100) | DTC | Substantially Equivalent | |
| K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES | DTB | Substantially Equivalent | |
| K872972 | TEMPORARY PACEMAKER ELECTRODE | LDF | Substantially Equivalent | |
| K870034 | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD | DTB | Substantially Equivalent | |
| K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | DTB | Substantially Equivalent | |
| K862949 | HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER | LQR | Substantially Equivalent | |
| K861493 | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH | DTB | Substantially Equivalent | |
| K862330 | MODIFIED OSCOR PY PACING LEADS | DTB | Substantially Equivalent | |
| K861403 | TB SERIES BIPOLAR PACING LEADS | LDF | Substantially Equivalent | |
| K854128 | OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE | DTB | Substantially Equivalent | |
| K850623 | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE | DTB | Substantially Equivalent | |
| K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | LDF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain