FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
K Number: K980583
·
Decision Apr 27, 1998
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
32
Review Days
69
Basic Information
- Device Name
- EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
- K Number
- K980583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIMS DELTEC, INC.
- Date Received
- February 17, 1998
- Decision Date
- April 27, 1998
- 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.
Clave Neutral-Displacement Needlefree Connectors
FDA 510(k)
FDA Class 2
·General Hospital
SteadiSet Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
JetCan® Pro Safety Huber Needle
FDA 510(k)
FDA Class 2
·General Hospital
Solution Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
Intravascular Extension Sets and Accessories
FDA 510(k)
FDA Class 2
·General Hospital
Lyka® PORT Needle Free Access Device (4170Y)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by SIMS DELTEC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | Mar 8, 2001 | Substantially Equivalent |
| K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM | Jun 8, 2000 | Substantially Equivalent |
| K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | Apr 27, 2000 | Substantially Equivalent |
| K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | Jan 27, 2000 | Substantially Equivalent |
| K992697 | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM | Nov 18, 1999 | Substantially Equivalent |
| K992880 | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM | Oct 19, 1999 | Substantially Equivalent |
| K991599 | CADD ADMINISTRATION SET | Jun 15, 1999 | Substantially Equivalent |
| K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | Jun 9, 1999 | Substantially Equivalent |
| K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | Jun 9, 1999 | Substantially Equivalent |
| K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | Feb 12, 1999 | Substantially Equivalent |