FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K Number: K861449
·
Decision Sep 16, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
38
Applicant Total
18
Review Days
152
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Basic Information
- Device Name
- VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
- K Number
- K861449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Exel Intl.
- Date Received
- April 17, 1986
- Decision Date
- September 16, 1986
- Product Code
- GIM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K926119 | EXEL HUBER INFUSION SET ROTATING WING | Aug 11, 1993 | Substantially Equivalent |
| K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) | Nov 21, 1990 | Substantially Equivalent |
| K903945 | EXEL A-V FISTULA SET | Nov 20, 1990 | Substantially Equivalent |
| K895770 | EXEL HUBER INFUSION SET | Jul 19, 1990 | Substantially Equivalent |
| K895768 | EXEL SAFELET CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895772 | EXEL INDWELLING CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895771 | EXEL SPINAL NEEDLES | Feb 16, 1990 | Substantially Equivalent |