CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS— 510(k) K984055
Substantially EquivalentSims Deltec, Inc.
FDA 510(k) clearance K984055 for CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS, Substantially Equivalent on 1999-01-29. Applicant: Sims Deltec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Deltec, Inc.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FOZ
view allMore 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 FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.