FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL DILATOR
K Number: K963388
·
Decision Mar 11, 1997
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
26
Review Days
195
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Basic Information
- Device Name
- VESSEL DILATOR
- K Number
- K963388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxxim Medical
- Date Received
- August 28, 1996
- Decision Date
- March 11, 1997
- 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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