# K900263: Antimicrobial Multi-Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jul 24, 1990 after 187 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 12 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 8 cite it directly.
7 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter (2007), 14 descendants of its own
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro (2000), 8 descendants of its own
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) (2012), 4 descendants of its own
- K190855: BD Acute Central Line (2019), 3 descendants of its own
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), 3 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2376-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- May 17, 2019 · Class II · Z-0053-2020: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
- Jul 3, 2018 · Class II · Z-2886-2018: One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5
- Apr 11, 2018 · Class II · Z-1985-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1984-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1333-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 27, 2017 · Class II · Z-1001-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- May 9, 2017 · Class II · Z-2337-2017: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infus
- May 3, 2012 · Class I · Z-1830-2012: Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
- Jul 29, 2010 · Not classified · Z-2496-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Feb 11, 2009 · Not classified · Z-1499-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Sep 16, 2003 · Not classified · Z-0082-04: wrong product in box

Source page: https://510kreport.com/device/K900263
Methodology: https://510kreport.com/methodology