FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUO-CATH FEMORAL
K Number: K771573
·
Decision Sep 15, 1977
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
2
Review Days
31
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Basic Information
- Device Name
- DUO-CATH FEMORAL
- K Number
- K771573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Device Laboratories
- Date Received
- August 15, 1977
- Decision Date
- September 15, 1977
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Medical Device Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K781110 | BANDAGE, COMPRESSION, FISTULAID | Aug 18, 1978 | Substantially Equivalent |