STRATO/INFUSAID TUNNELER— 510(k) K950987
Substantially EquivalentStrato/Infusaid, Inc.
FDA 510(k) clearance K950987 for STRATO/INFUSAID TUNNELER, Substantially Equivalent on 1995-06-02. Applicant: Strato/Infusaid, Inc.. Device class: 2.
Clearance details
- Applicant
- Strato/Infusaid, Inc.
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwood, MA, US
Recent devices under product code LJS
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More clearances from Strato/Infusaid, Inc.
view all- K960391 — STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
- K953529 — STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
- K954720 — STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS
- K953254 — STRATO/INFUSAID INFUSE-A-KIT
- K953256 — STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.