ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology— 510(k) K161313
Substantially EquivalentArrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K161313 for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology, Substantially Equivalent on 2016-08-24. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Product code
- Code PND
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code PND
view allMore 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
- K160018 — Arrow Quickflash Arterial Catheterization Device
- K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
- K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
Adverse events under product code PND
product code PND- Injury
- 149
- Malfunction
- 695
- Other
- 1
- Total
- 845
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 K161313
K-number listed on FDA's recall record- Z-0102-2023 — ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
- Z-1818-2019 — Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161313.
Data sourced from openFDA. This site is unofficial and independent of the FDA.