Panels › Cardiovascular › Product code DXT · Class 2
Injector And Syringe, Angiographic
Regulation 870.1650
7510(k)s in 12 months (211 all time)
8recalls in 12 months (70 all time)
58recalls that name a 510(k)
Top companies in DXT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bayer Medical Care, Inc. MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System;
Catalog number: FLEXS-150-QFT; Open, Classified |
DXT | K182273 |
| Jun 3, 2026 | Bayer Medical Care, Inc. Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System;
Catalog number: AVA 500 MPAT (Part 2 of 2);
Affected material numbers: 87629007 Open, Classified |
DXT | K050456 |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369;
2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C Open, Classified |
DXT | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1;
3) EP MANIFOLD KIT, Model Number: VASC1018A Open, Classified |
DXT | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Syringes:
1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR;
2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR;
3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP Open, Classified |
DXT | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Namic Syringes:
1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; Open, Classified |
DXT | None listed |
| Apr 7, 2026 | Medline Industries, LP NAMIC Angiographic Control Syringe, labeled as follows:
1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007;
2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007;
3. MTS,SYRINGE,8ML,TR/ Open, Classified |
DXT | K113198 |
| Apr 7, 2026 | Medline Industries, LP NAMIC Angiographic Syringe, labeled as follows:
1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027;
2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007;
3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medli Open, Classified |
DXT | K873955 |
| Oct 11, 2024 | Merit Medical Systems, Inc. MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. IntelliSystem Inflation Device, REF: IN1525/D Open, Classified |
DXT | K884913 |
| Oct 11, 2024 | Merit Medical Systems, Inc. DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Open, Classified |
DXT | K160107 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C Open, Classified |
DXT | K083523 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Melrose Wakefield Hospital REF K05T-2159
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syring Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syri Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch s Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar REF IN2130
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters Open, Classified |
DXT | K011811 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP;
2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056;
3) MSC - JOHN MUIR MC, Pack Number 150206 Open, Classified |
DXT | None listed |
| Nov 3, 2023 | B. Braun Medical, Inc. 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system. Open, Classified |
DXT | None listed |
| Nov 3, 2023 | B. Braun Medical, Inc. 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system. Open, Classified |
DXT | None listed |
| Sep 14, 2021 | Bayer Medical Care, Inc. The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is des Terminated |
DXT | K132928 |
| Apr 6, 2021 | LeMaitre Vascular, Inc. LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-0 Terminated |
DXT | K973334 |
| Oct 5, 2020 | Bayer Medical Care, Inc. Brand Name: MEDRAD Stellant FLEX Syringe Kits
Common Name: Angiographic Syringe
Catalog/REF Number: FLEXD-150-SCS
Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike Terminated |
DXT | K192370 |
| Dec 14, 2018 | Bayer Medical Care, Inc. MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Med Terminated |
DXT | K023183 K112086 +2 |
| Nov 12, 2018 | Bracco Injeneering S.A. Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems
SKU 017344/6720
Empower FastLoad" CT Syringe Pack is a steril Terminated |
DXT | K933846 |
| Aug 2, 2016 | Bayer Healthcare Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Catalog Number # CWKS DISPLAY
Serial Numbers
The Medrad Stellant CT Injector System is intended for the specific pur Terminated |
DXT | K082905 |
| Jun 9, 2016 | Bayer Healthcare Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit
Usage:
The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery Terminated |
DXT | K143538 |
| Feb 2, 2016 | Acist Medical Systems ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico.
The manifold body is identical in the BT2000 Terminated |
DXT | K052744 K984231 |
| Sep 16, 2015 | Bayer Healthcare Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing Terminated |
DXT | K132928 |
| May 28, 2015 | Medrad Inc dba Bayer R&I MEDRAD Stellant CT Injector System with Certegra
Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (C Terminated |
DXT | K082905 |
| Apr 18, 2013 | Acist Medical Systems ACIST Medical Systems Inc.
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. Terminated |
DXT | K040298 |
| Feb 21, 2013 | Medrad Inc MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to Terminated |
DXT | K050456 |
| Jul 26, 2012 | Mallinckrodt Inc The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches.
The Handi-Fil Disposa Terminated |
DXT | K781334 |
| Feb 29, 2012 | Mallinckrodt Inc Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch, with 100 pouches per case; Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico.
Sterile, The purpos Terminated |
DXT | K882329 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per ca Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case.
Sterile, Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case.
Sterile, Terminated |
DXT | K984088 |
| Jan 19, 2012 | Mallinckrodt Inc Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico.
The Handi-Fil Disposable Syringe Fill Tube is a sterile Terminated |
DXT | K781334 |
| Nov 2, 2011 | Medrad Inc Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.
Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into Terminated |
DXT | K023183 |
| Jul 22, 2011 | Medrad Inc MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL
Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions Terminated |
DXT | K050456 |
| Nov 15, 2010 | Medrad Inc MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe
The contents of the package are intended to be used in the delivery of contrast me Terminated |
DXT | None listed |
| Jul 9, 2010 | Medrad Inc Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK Terminated |
DXT | K023183 |
| Mar 23, 2010 | Medrad Inc Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231. Terminated |
DXT | K050456 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220 Terminated |
DXT | K884913 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe Terminated |
DXT | K884913 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices. Terminated |
DXT | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation and deflation of interventional devices Terminated |
DXT | K884913 |
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