FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE I.V. ADMINISTRATION SET
K Number: K872953
·
Decision Jan 6, 1988
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
14
Review Days
161
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE I.V. ADMINISTRATION SET
- K Number
- K872953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mac Lee Medical Products
- Date Received
- July 29, 1987
- Decision Date
- January 6, 1988
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Mac Lee Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Nov 17, 1987 | Substantially Equivalent |
| K870995 | SCALP VEIN SET | Jul 31, 1987 | Substantially Equivalent |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K841710 | MAC LEE VAGINAL IRRIGATOR | Jun 19, 1984 | Substantially Equivalent |