FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
K Number: K913201
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
31
Review Days
77
Basic Information
- Device Name
- PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
- K Number
- K913201
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OSCOR MEDICAL CORP.
- Date Received
- July 8, 1991
- Decision Date
- September 23, 1991
- Product Code
- DTB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTB), ordered by most recent decision date.
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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Other Clearances by OSCOR MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | Apr 1, 1997 | Substantially Equivalent - Subject to Tracking & PMS |
| K925168 | MISCELLANEOUS PACING LEAD | May 3, 1994 | Substantially Equivalent |
| K923621 | EXTERNAL DEMAND PACEMAKER | May 19, 1993 | Substantially Equivalent |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | Feb 4, 1992 | Substantially Equivalent |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | Jan 27, 1992 | Substantially Equivalent |
| K915008 | PERMANENT PACING PAD, MODIFICATION | Jan 27, 1992 | Substantially Equivalent |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | Sep 23, 1991 | Substantially Equivalent |