FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHFINDER II ANGIOGRAPHIC CATHETER
K Number: K990173
·
Decision Dec 21, 1999
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
497
Applicant Total
26
Review Days
336
Basic Information
- Device Name
- PATHFINDER II ANGIOGRAPHIC CATHETER
- K Number
- K990173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAXXIM MEDICAL
- Date Received
- January 19, 1999
- Decision Date
- December 21, 1999
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
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