FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
K Number: K910154
·
Decision Apr 9, 1991
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
645
Review Days
85
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Basic Information
- Device Name
- USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
- K Number
- K910154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- January 14, 1991
- Decision Date
- April 9, 1991
- Product Code
- DOY
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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