FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
K Number: K990083
·
Decision Feb 12, 1999
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
32
Review Days
32
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Basic Information
- Device Name
- CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
- K Number
- K990083
- 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
- January 11, 1999
- Decision Date
- February 12, 1999
- 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 |
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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 |
| K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | Jun 9, 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 |
| K984055 | CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS | Jan 29, 1999 | Substantially Equivalent |