FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALBUMIN INTRAVENOUS ADMINISTRATION SET
K Number: K791672
·
Decision Oct 26, 1979
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
27
Review Days
59
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
- ALBUMIN INTRAVENOUS ADMINISTRATION SET
- K Number
- K791672
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Delmed, Inc.
- Date Received
- August 28, 1979
- Decision Date
- October 26, 1979
- 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 Delmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895142 | ENTERAL PUMP SET WITH ENTERAL SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895650 | ENTERAL PUMP SET W/ENTERA-FLO SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895329 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA | Oct 2, 1990 | Substantially Equivalent |
| K894506 | ENTERA-FLO ENTERAL FEEDING PUMP | Aug 6, 1990 | Substantially Equivalent |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | Jul 27, 1990 | Substantially Equivalent |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | Jul 27, 1990 | Substantially Equivalent |
| K900106 | CLOSED DISCONNECT SYSTEM | Jul 16, 1990 | Substantially Equivalent |
| K895246 | FRENTA(R) DUO-SET | May 2, 1990 | Substantially Equivalent |
| K895330 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA | May 2, 1990 | Substantially Equivalent |
| K895919 | ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III | May 2, 1990 | Substantially Equivalent |