ARROW PICC POWERED BY ARROW VPS STYLET— 510(k) K121941
Substantially EquivalentArrow International (Subsidiary of Teleflex Inc.)
FDA 510(k) clearance K121941 for ARROW PICC POWERED BY ARROW VPS STYLET, Substantially Equivalent on 2012-09-07. Applicant: Arrow International (Subsidiary of Teleflex Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International (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 (Subsidiary of Teleflex Inc.)
view allAdverse 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 K121941
K-number listed on FDA's recall record- Z-2591-2023 — Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
- Z-0690-2018 — ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
- Z-0601-2018 — ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
- Z-0180-2018 — ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
- Z-0181-2018 — ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
- Z-0207-2016 — ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term 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. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
- 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
- Z-1030-2015 — Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
- Z-1494-2014 — Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121941.
Data sourced from openFDA. This site is unofficial and independent of the FDA.