FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K Number: K925099
·
Decision Jun 22, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
34
Review Days
257
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Basic Information
- Device Name
- POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
- K Number
- K925099
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Possis Medical, Inc.
- Date Received
- October 8, 1992
- Decision Date
- June 22, 1993
- 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
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
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