FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL DILATOR
K Number: K832595
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
19
Applicant Total
883
Review Days
29
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Basic Information
- Device Name
- VESSEL DILATOR
- K Number
- K832595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4475
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- August 2, 1983
- Decision Date
- August 31, 1983
- Product Code
- DWP
- 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 |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | FDA class 2 | Cardiovascular |
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