FDA 510(k)
FDA class 3
Unknown
🇺🇸 United States
VASCOTWIST 9/60
K Number: K920662
·
Decision Nov 24, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
3
Review Days
649
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Basic Information
- Device Name
- VASCOTWIST 9/60
- K Number
- K920662
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Vascor Medical Corp.
- Date Received
- February 14, 1992
- Decision Date
- November 24, 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 |
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