ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN— 510(k) K083763
Substantially EquivalentR4 Vascular, Inc.
FDA 510(k) clearance K083763 for ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN, Substantially Equivalent on 2009-03-16. Applicant: R4 Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- R4 Vascular, 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
- Maple Grove, MN, US
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More clearances from R4 Vascular, Inc.
view all- K131329 — VECTOR PTA BALLOON DILATATION CATHETER
- K121385 — VECTOR
- K100169 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER
- K091506 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
- K092040 — PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
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.