ClearanceBrief
510(k) K810675 ยท DQX Wire, Guide, Catheter

ARROW RADIAL ARTERY CATHETERIZATION SET

ApplicantArrow Intl., Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Mar 27, 1981
ReceivedMar 12, 1981
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K810675

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018
Open, Classified
DQXNone listed
Sep 26, 2024ARROW INTERNATIONAL Inc.
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-
Open, Classified
DQXNone listed
Dec 12, 2019Arrow International Inc
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow
Open, Classified
DQXNone listed
Apr 11, 2018Arrow International Inc
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Terminated
DQXNone listed
Apr 11, 2018Arrow International Inc
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Terminated
DQXNone listed
Apr 11, 2018Arrow International Inc
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Terminated
DQXNone listed
Apr 11, 2018Arrow International Inc
Arterial Catheterization Kit; Product Codes: ASK-04020-DH
Terminated
DQXNone listed
Apr 11, 2018Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
Terminated
DQXNone listed
Apr 11, 2018Arrow International Inc
Arterial Catheterization Kit; Product Code:NA-04550-1A
Terminated
DQXNone listed
Dec 22, 2017Arrow International Inc
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04018
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04020
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04020-C
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04120
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04122
Terminated
DQXNone listed
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04220
Terminated
DQXNone listed
Jul 10, 2017Arrow International Inc
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Terminated
FMINone listed
May 9, 2017Arrow International Inc
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or
Terminated
DQXNone listed
Sep 7, 2016Arrow International Inc
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Terminated
DQXNone listed
Sep 7, 2016Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when us
Terminated
DQXNone listed
Jul 12, 2016Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization de
Terminated
DQXNone listed
Jul 12, 2016Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization de
Terminated
DQXNone listed
Oct 14, 2014Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Terminated
DQYNone listed
Feb 17, 2011Arrow International Inc
ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kit
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery catheterization kit
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100. Cardiovascular catheterization kit
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1. Cardiovascular catheter wire guide
Terminated
DQXNone listed
Feb 17, 2011Arrow International Inc
ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial artery catheterization set
Terminated
DQXNone listed
Sep 25, 2010Arrow International Inc
Arterial Catheterization Set
Terminated
DQXNone listed
Sep 25, 2010Arrow International Inc
Femoral Artery Catheterization Set
Terminated
DQXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.