510(k) K011761 ยท DYB Introducer, Catheter
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Oct 31, 2001 |
| Received | Jun 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/GU-04020;
PSI KIT: 8.5 FR/AK-09803-CDC;
PSI KIT: 9 FR/AK-09903-CDC;
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1;
PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
PSI KIT: 9 FR X 10 Open, Classified |
DYB | None listed |
| Aug 6, 2019 | Arrow International Inc 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters
Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue pe Terminated |
DYB | None listed |
| Apr 11, 2018 | Arrow International Inc MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP Terminated |
FOZ | None listed |
| Dec 22, 2017 | Arrow International Inc (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requ Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue
Product Usage:
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, bu Terminated |
FOZ | None listed |
| May 9, 2017 | Arrow International Inc 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
2) ARROWg+ard Blue PSI Kit
3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
4) ARROWg+ard Blue PSI Kit
The MACTM two-Lumen Cent Terminated |
FOZ | None listed |
| Sep 30, 2015 | Arrow International Inc Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Terminated |
FOZ | None listed |
| Oct 14, 2014 | Arrow International Inc Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. Terminated |
DQY | None listed |
| Mar 5, 2010 | Arrow International Inc MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.