FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERI-GUARD PERICARDIAL PATCH
K Number: K842066
·
Decision Dec 30, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
3
Review Days
616
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Basic Information
- Device Name
- PERI-GUARD PERICARDIAL PATCH
- K Number
- K842066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Genetic Laboratories, Inc.
- Date Received
- April 23, 1984
- Decision Date
- December 30, 1985
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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