R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005— 510(k) K071361

Substantially Equivalent

R4 Vascular, Inc.

FDA 510(k) clearance K071361 for R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005, Substantially Equivalent on 2007-08-20. Applicant: R4 Vascular, Inc..

Clearance details

Applicant: R4 Vascular, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2007-05-15
Decision date: 2007-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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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, 2020-01-01 through 2026-04-23. 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.