FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K Number: K862006
·
Decision Jun 27, 1986
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
497
Applicant Total
315
Review Days
31
Basic Information
- Device Name
- STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
- K Number
- K862006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CORDIS CORP.
- Date Received
- May 27, 1986
- Decision Date
- June 27, 1986
- 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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