FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULAR CATHETER
K Number: K831191
·
Decision May 9, 1983
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
105
Review Days
27
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Basic Information
- Device Name
- VASCULAR CATHETER
- K Number
- K831191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Medrad, Inc.
- Date Received
- April 12, 1983
- Decision Date
- May 9, 1983
- 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 |
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|---|---|---|---|
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| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | Oct 14, 2011 | Substantially Equivalent |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | May 24, 2011 | Substantially Equivalent |
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