FDA Product Code
FDA Product Code DXT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1650
510(k) Clearances — 210 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K991103 | MODIFICATION TO ACIST CL 100H | Acist Medical Systems | 2000-05-31 | Traditional | PDF ↗ |
| K000013 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 | Acist Medical Systems | 2000-03-28 | Special | PDF ↗ |
| K983826 | 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM | Unimachs Corp. | 2000-03-23 | Traditional | PDF ↗ |
| K993774 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH | Acist Medical Systems | 1999-12-07 | Special | PDF ↗ |
| K984088 | OPTISTAR MR INJECTOR SYSTEM | Mallinckrodt Inc., Liebel-Flarsheim Business | 1999-12-06 | Traditional | PDF ↗ |
| K993728 | MEDRAD ENVISION CT INJECTOR SYSTEM | Medrad, Inc. | 1999-11-26 | Special | PDF ↗ |
| K991557 | MEDRAD VISTRON CT INJECTOR SYSTEM | Medrad, Inc. | 1999-07-21 | Special | PDF ↗ |
| K984418 | UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET | Medrad, Inc. | 1999-03-11 | Traditional | PDF ↗ |
| K982814 | MEDRAD VISTRON CT INJECTOR SYSTEM | Medrad, Inc. | 1998-10-09 | Special | PDF ↗ |
| K973334 | OZ POWER SYRINGE | Cardiovascular Innovations | 1998-04-03 | Traditional | PDF ↗ |
| K963982 | ACIST ANGIOGRAPHIC INJECTOR | Invasatec | 1997-12-05 | Traditional | PDF ↗ |
| K973230 | MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) | Merit Medical Systems, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | Coeur Laboratories, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K963071 | ANGIOMAT ILLUMENA | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997-09-23 | Traditional | PDF ↗ |
| K964642 | MEDRAD DISPOSABLE SYRINGES | Medrad, Inc. | 1997-04-29 | Traditional | PDF ↗ |
| K962141 | VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 | B.Braun Medical, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY | Contour Fabricators of Florida, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K960674 | CONTRAST INJECTION LINES | B.Braun Medical, Inc. | 1996-09-19 | Traditional | PDF ↗ |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | Coeur Laboratories, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K960430 | CONTROL SYRINGE | Scientific Device Manufacturer, LLC | 1996-08-06 | Traditional | PDF ↗ |
| K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K955381 | B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT | B.Braun Medical, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K935668 | MEDRAD SPECTRIS MR INJECTOR | Medrad, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K951802 | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT | Scimed Life Systems, Inc. | 1995-07-21 | Traditional | PDF ↗ |
| K934086 | MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE | Medrad, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K942381 | LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING | Apogee, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K944875 | ANGIOMAT 3000, 6000, CT INJECTOR | Lievel-Flarsheim Co. | 1995-01-04 | Traditional | PDF ↗ |
| K933846 | ANGIOGRAPHY SYRINGE KITS | Angiodynamics, Div. E-Z-Em, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K933908 | MEDRAD CT CUSTOM CONVENIENCE KIT | Medrad, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K932083 | XDCS-100 | Microwave Medical Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K923117 | CAVERNOSOMETRY MODULE FOR MENUET | Dantec Medical, Inc. | 1993-02-22 | Traditional | PDF ↗ |
| K924116 | MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD | Medrad, Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K913624 | MEDRAD MCT-PLUS INJECTOR | Medrad, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K920135 | MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE | Medroyal, Inc. | 1992-07-24 | Traditional | PDF ↗ |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | Mallinckrodt Group, Inc. | 1992-02-04 | Traditional | PDF ↗ |
| K910594 | TRAC-WRIGHT SYSTEM, MODEL TW2 | Dow Corning Wright | 1991-09-23 | Traditional | PDF ↗ |
| K905819 | MEDRAD VARIBLE INFUSION INJECTOR | Medrad, Inc. | 1991-09-16 | Traditional | PDF ↗ |
| K911166 | DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 | Diagnostic Ultrasound Corp. | 1991-08-15 | Traditional | PDF ↗ |
| K911549 | INJECTOR FILL TUBE | The R Group | 1991-07-18 | Traditional | PDF ↗ |
| K910873 | BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-29 | Traditional | PDF ↗ |
| K904994 | CLOSED SYSTEM FLUSH SET | Argon Medical Corp. | 1991-01-15 | Traditional | PDF ↗ |
| K902377 | ANGEFLATOR(TM) | Angeion Corp. | 1990-12-13 | Traditional | PDF ↗ |
| K902475 | CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS | Cardio-Pak | 1990-12-03 | Traditional | PDF ↗ |
| K904212 | HIGH-PRESSURE CONNECTOR TUBE | Mallinckrodt Medical | 1990-12-03 | Traditional | PDF ↗ |
| K903494 | MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP | Life-Tech Intl., Inc. | 1990-10-17 | Traditional | PDF ↗ |
| K903495 | LIQUID DETECTOR | Life-Tech Intl., Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K903390 | MEDRAD MARK V-PLUS INJECTOR | Medrad, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K902221 | MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE | Mallinckrodt Group, Inc. | 1990-08-08 | Traditional | PDF ↗ |
| K901382 | ISOFLO(TM) HIGH PRESSURE INJECTION LINES | Healthdyne Cardiovascular, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K900034 | ANGIO-MAX | Accumed Systems, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K896415 | USCI PRESTO DISPOSABLE INFLATION DEVICE | C.R. Bard, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K895318 | B-D ANGIOGRAPHIC CONTROL SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-01-19 | Traditional | PDF ↗ |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | Coeur Laboratories, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K890208 | HIGH PRESSURE CONNECTING SETS | E-Z-Em, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K884913 | MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) | Merit Medical Systems, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K890898 | MODEL 611101 CONTRAST INJECTION DEVICE | Medtronic Versaflex, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K883769 | EXCEL INFLATE-AID | Medical Profiles, Inc. | 1988-12-01 | Traditional | PDF ↗ |
| K883452 | ACS INDEFLATOR P/T 20 | Advanced Cardiovascular Systems, Inc. | 1988-10-14 | Traditional | PDF ↗ |
| K882329 | L-F COILED EXTENSION TUBING | Mallinckrodt Group, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K881521 | MODIFIED SERVO SYRINGE | Engineering, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K880877 | CONTRAST INJECTION DEVICE | Med-West, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K880987 | INJECTOR HANDLE WITH SYRINGE | Applied Vascular Devices, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K880493 | MEDRAD MICROPROCESSOR CT INJECTION SYSTEM | Medrad, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880310 | ANGIO DRAPE PACK ACP-010FM | Arrow Intl., Inc. | 1988-04-22 | Traditional | PDF ↗ |
| K873410 | DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE | Blood Gas Supply Co. | 1988-03-25 | Traditional | PDF ↗ |
| K875324 | MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES | Schneider-Shilley (Usa) | 1988-03-25 | Traditional | PDF ↗ |
| K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC | Merit Medical Systems, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K873173 | MEDRAD MRI INJECTION SYSTEM | Medrad, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K873955 | NAMIC ANGIOGRAPHIC SYRINGE | North American Instrument Corp. | 1988-02-05 | Traditional | PDF ↗ |
| K873597 | TUBING, POLYETHYLENE | Coeur Laboratories, Inc. | 1987-11-12 | Traditional | PDF ↗ |
| K872981 | ACS INDEFLATOR PLUS (MODIFICATION #2) | Advanced Cardiovascular Systems, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K873687 | ANGIOMAT CT INJECTOR | Mallinckrodt Group, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K872472 | SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE | Angiomedics, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K871129 | CAVROPUMP | Life-Tech Intl., Inc. | 1987-08-28 | Traditional | PDF ↗ |
| K863596 | CHIN-FOGARTY INFLATION DEVICE | American Edwards Laboratories | 1986-11-20 | Traditional | PDF ↗ |
| K863537 | CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY | Cordis Corp. | 1986-10-31 | Traditional | PDF ↗ |
| K863037 | USCI (R) DISPOSABLE INFLATION DEVICE | C.R. Bard, Inc. | 1986-09-23 | Traditional | PDF ↗ |
| K862547 | MECHANICAL INFLATION DEVICE | American Edwards Laboratories | 1986-09-03 | Traditional | PDF ↗ |
| K860204 | ANGIOMAT 6000 | Mallinckrodt Group, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K860842 | ANGIOJECT | Target Therapeutics | 1986-04-23 | Traditional | PDF ↗ |
| K850861 | ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE | Medical Components, Inc. | 1986-02-18 | Traditional | PDF ↗ |
| K854310 | ACS INDEFLATOR (MODIFICATION) | Advanced Cardiovascular Systems, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | Tronomed, Inc. | 1985-07-24 | Traditional | PDF ↗ |
| K851402 | LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE | Medi-Tech, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K844045 | ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT | Advanced Cardiovascular Systems, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K841493 | MODEL 1000 APC-ANGIOPLASTY PRESSURE | E.A. Fischione Instrument Mfg. | 1984-06-11 | Traditional | PDF ↗ |
| K840281 | ANGIOGRAPHIC DRAPE PACKS | Medrad, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K833645 | CONTRAST MEDIA INJECT. SET CMS | Gish Biomedical, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834107 | ANGIOPLASTY INFLATION DEVICE & CARTR | Cordis Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K833138 | DIGITAL INJECTOR SYS | Sybron Corp. | 1983-11-14 | Traditional | PDF ↗ |
| K830754 | BLOOD PRESSURE MONITORING KITS,WALRUS | Medical Parameters, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K830609 | INFLATION DEVICE | Interventional Medical, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | Coeur Laboratories, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K823192 | TUOHY-BORST ADAPTER W/SIDE ARM | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823340 | CLEAR VINYL MONITORING CONNECTOR | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823254 | REUSABLE METAL STOPCOCK | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823253 | VERTEX MONITORING CATHETER | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823238 | INJECTION FILL TUBE | Vetrex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823256 | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K823190 | BACKSTOP VALVE W/SIDE ARM | Vertex Medical Corp. | 1982-12-30 | Traditional | PDF ↗ |
Product code DXT · Class II · Cardiovascular. Data: openFDA.