510(k) K810675 ยท DQX Wire, Guide, Catheter
ARROW RADIAL ARTERY CATHETERIZATION SET
| Applicant | Arrow Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 27, 1981 |
| Received | Mar 12, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810675
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW 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 |
DQX | None listed |
| Sep 26, 2024 | ARROW 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 |
DQX | None listed |
| Dec 12, 2019 | Arrow 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 |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Radial Arterial Access Kit; Product Code: ASK-04001-BID2 Terminated |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1 Terminated |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1 Terminated |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Arterial Catheterization Kit; Product Codes: ASK-04020-DH Terminated |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM Terminated |
DQX | None listed |
| Apr 11, 2018 | Arrow International Inc Arterial Catheterization Kit; Product Code:NA-04550-1A Terminated |
DQX | None listed |
| Dec 22, 2017 | Arrow 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 |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04018 Terminated |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04020 Terminated |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04020-C Terminated |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04120 Terminated |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04122 Terminated |
DQX | None listed |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04220 Terminated |
DQX | None listed |
| Jul 10, 2017 | Arrow 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 |
FMI | None listed |
| May 9, 2017 | Arrow 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 |
DQX | None listed |
| Sep 7, 2016 | Arrow International Inc Arterial Line Catheterization Kit with Sharps Safety Features
Permits access to the peripheral arterial circulation or to other small vessels. Terminated |
DQX | None listed |
| Sep 7, 2016 | Arrow 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 |
DQX | None listed |
| Jul 12, 2016 | Arrow 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 |
DQX | None listed |
| Jul 12, 2016 | Arrow 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 |
DQX | 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 |
| Feb 17, 2011 | Arrow International Inc ARTERIAL LINE KIT/Product SKU (Code) AK-04510
Arterial line kit Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC.
Arterial catheterization kit Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH.
Cardiovascular artery catheterization kit Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF.
Radial artery catheterization kit Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100.
Cardiovascular catheterization kit Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1.
Cardiovascular catheter wire guide Terminated |
DQX | None listed |
| Feb 17, 2011 | Arrow International Inc ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1.
Arterial access tray for radial artery catheterization set Terminated |
DQX | None listed |
| Sep 25, 2010 | Arrow International Inc Arterial Catheterization Set Terminated |
DQX | None listed |
| Sep 25, 2010 | Arrow International Inc Femoral Artery Catheterization Set Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.