FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, CARDIOVASCULAR, BALLOON TYPE
K Number: K883852
·
Decision Dec 7, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
2
Review Days
450
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Basic Information
- Device Name
- CATHETER, CARDIOVASCULAR, BALLOON TYPE
- K Number
- K883852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Wb Intl., Inc.
- Date Received
- September 13, 1988
- Decision Date
- December 7, 1989
- Product Code
- DXE
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Wb Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K885089 | SURGICAL GLOVES | Jun 22, 1989 | Substantially Equivalent |