FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K Number: K992231
·
Decision Jul 23, 1999
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
68
Applicant Total
112
Review Days
21
Basic Information
- Device Name
- FOUNTAIN Infusion Catheter and Occluding Guide Wire
- K Number
- K992231
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MERIT MEDICAL SYSTEMS, INC.
- Date Received
- July 2, 1999
- Decision Date
- July 23, 1999
- Product Code
- QEY
- 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
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