CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS— 510(k) K153487
Substantially EquivalentArrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K153487 for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS, Substantially Equivalent on 2016-02-04. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, 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
- Special
- Location
- Reading, PA, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
view all- K180395 — EZ-IO Intraosseous Vascular Access System
- K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
- K160018 — Arrow Quickflash Arterial Catheterization Device
- K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
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 →
Recalls naming K153487
K-number listed on FDA's recall record- Z-0001-2024 — Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
- Z-1807-2019 — Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44063 VPS2
- Z-1808-2019 — Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45041 VPS2
- Z-1810-2019 — Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
- Z-1365-2019 — Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
- Z-1366-2019 — Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
- Z-3199-2018 — 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
- Z-3200-2018 — 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.