CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER— 510(k) K990083
Substantially EquivalentSims Deltec, Inc.
FDA 510(k) clearance K990083 for CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER, Substantially Equivalent on 1999-02-12. Applicant: Sims Deltec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Deltec, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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More clearances from Sims Deltec, Inc.
view all- K010426 — PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
- K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
- K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
- K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
- K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.