FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRAVENOUS TRANSFER SET (INTRAFIX)
K Number: K760380
·
Decision Nov 2, 1976
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
13
Applicant Total
13
Review Days
89
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Basic Information
- Device Name
- INTRAVENOUS TRANSFER SET (INTRAFIX)
- K Number
- K760380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- B. Braun Instruments
- Date Received
- August 5, 1976
- Decision Date
- November 2, 1976
- Product Code
- JCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JCY | Catheter, Infusion | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCY), ordered by most recent decision date.
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
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CHEMOTHERAPY INFUSION CATHETER
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Other Clearances by B. Braun Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K760384 | STOPPERS | Nov 2, 1976 | Substantially Equivalent |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | Nov 2, 1976 | Substantially Equivalent |
| K760391 | CATHETER, VEIN (BRAUNULA) | Nov 2, 1976 | Substantially Equivalent |
| K760390 | CATHETER, VEIN (BRAUNULA T) | Nov 2, 1976 | Substantially Equivalent |
| K760387 | CATHETER, CAVA (CAVAFIX) | Nov 2, 1976 | Substantially Equivalent |
| K760385 | EXTENSION SETS | Nov 2, 1976 | Substantially Equivalent |
| K760383 | STOPCOCKS | Nov 2, 1976 | Substantially Equivalent |
| K760392 | SYRINGES | Nov 2, 1976 | Substantially Equivalent |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | Nov 2, 1976 | Substantially Equivalent |
| K760382 | CONNECTORS | Nov 2, 1976 | Substantially Equivalent |