VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET— 510(k) K103255
Substantially EquivalentVasonova, Inc.
FDA 510(k) clearance K103255 for VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET, Substantially Equivalent on 2011-02-18. Applicant: Vasonova, Inc.. Device class: 2.
Clearance details
- Applicant
- Vasonova, Inc.
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code OBJ
view allMore clearances from Vasonova, Inc.
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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 →
Recalls naming K103255
K-number listed on FDA's recall record- Z-0179-2018 — Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
- Z-2170-2017 — Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
- Z-2462-2015 — PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
- Z-2489-2015 — Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103255.
Data sourced from openFDA. This site is unofficial and independent of the FDA.