FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUBLE LUMEN CATHETER
K Number: K872248
·
Decision Aug 12, 1987
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
497
Applicant Total
315
Review Days
61
Basic Information
- Device Name
- DOUBLE LUMEN CATHETER
- K Number
- K872248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CORDIS CORP.
- Date Received
- June 12, 1987
- Decision Date
- August 12, 1987
- 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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