FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
K Number: K971293
·
Decision Jun 27, 1997
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
14
Review Days
81
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
- LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
- K Number
- K971293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Mfg., Inc.
- Date Received
- April 7, 1997
- Decision Date
- June 27, 1997
- 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 Abbott Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981457 | ALBP | May 27, 1998 | Substantially Equivalent |
| K981232 | CA | May 18, 1998 | Substantially Equivalent |
| K981231 | CO2 | May 12, 1998 | Substantially Equivalent |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Jul 3, 1997 | Substantially Equivalent |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Oct 3, 1995 | Substantially Equivalent |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Sep 25, 1995 | Substantially Equivalent |
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP | Jul 24, 1995 | Substantially Equivalent |
| K943691 | IMX FOLATE | Mar 23, 1995 | Substantially Equivalent |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Dec 12, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K941214 | LIFESHIELD EXTENSION SET | Oct 3, 1994 | Substantially Equivalent |