# K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 14, 2000 after 301 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895417 (1990). 2 ancestors in all.
8 later devices descend from it; 5 cite it directly.
5 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.
- K895417: Arrow Large-Bore Dual Lumen Hemodialysis Kit, Arrow Intl., Inc. (1990) Summary page 1.

## Most influential descendants
- K122091: Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (2013), 1 descendant of its own
- K053589: Long-Term Hemodialysis Catheters with Biobloc Coating (2006), 1 descendant of its own
- K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port (2001), 1 descendant of its own
- K161504: Cook Turbo-Flo HD Acute Hemodialysis  Catheter Set/Tray (2017), 0 descendants of its own
- K143102: Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (2015), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2373-2026: 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
- Dec 22, 2017 · Class II · Z-1336-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Oct 17, 2017 · Class II · Z-0658-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- May 9, 2017 · Class II · Z-2334-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Feb 18, 2004 · Not classified · Z-0639-04: catheter slips out of the suture wing during use.

## Indications for use
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue® antimicrobial surface in decreasing catheter-related infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing mfectlons, nor is it indicated for long-term use.

Source page: https://510kreport.com/device/K993933
Methodology: https://510kreport.com/methodology