FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K Number: K890277
·
Decision Mar 10, 1989
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
31
Review Days
51
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Basic Information
- Device Name
- HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
- K Number
- K890277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Oscor Medical Corp.
- Date Received
- January 18, 1989
- Decision Date
- March 10, 1989
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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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 |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |