FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
K Number: K931377
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
354
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
- SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
- K Number
- K931377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mcgaw, Inc.
- Date Received
- March 18, 1993
- Decision Date
- March 7, 1994
- 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 Mcgaw, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | Oct 7, 1997 | Substantially Equivalent |
| K955594 | SAFELINE I.V. BAG ACCESS DEVICE | Mar 6, 1996 | Substantially Equivalent |
| K955595 | SAFELINE MULTIDOSE VIAL ADAPTER | Mar 6, 1996 | Substantially Equivalent |
| K941244 | SAFELINE SYSTEM TURN LOCK CANNULA | Nov 29, 1994 | Substantially Equivalent |
| K932165 | INTRAVASCULAR ADMINISTRATION SET | Apr 13, 1994 | Substantially Equivalent |
| K932856 | IRRIGATION ACCESS CAP | Jan 26, 1994 | Substantially Equivalent |
| K922637 | HORIZON PUMP Y-TYPE BLOOD SET | Jun 4, 1993 | Substantially Equivalent |
| K921860 | MODIFICATION TO IV SPIKE | Jul 30, 1992 | Substantially Equivalent |
| K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | Dec 18, 1991 | Substantially Equivalent |
| K913056 | VOLUMETRIC INFUSION PUMP, MODIFICATION | Sep 6, 1991 | Substantially Equivalent |