FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF TISSUE DILATOR
K Number: K862288
·
Decision Aug 19, 1986
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
164
Review Days
64
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Basic Information
- Device Name
- MODIFICATION OF TISSUE DILATOR
- K Number
- K862288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- June 16, 1986
- Decision Date
- August 19, 1986
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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