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Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

9510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
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Top companies in FOZ

DateFirm and productCodeLinked 510(k)
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Open, Classified
FOZK071538
Apr 22, 2026ARROW INTERNATIONAL, LLC
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (
Open, Classified
FOZK071538
Apr 6, 2026Cook Incorporated
COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G448
Open, Classified
FOZK081113
Apr 6, 2026Cook Incorporated
COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part
Open, Classified
FOZK033843
K081113
Apr 6, 2026Cook Incorporated
COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G
Open, Classified
FOZK081113
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Open, Classified
FOZNone listed
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Open, Classified
FOZK201075
Jun 23, 2025Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Open, Classified
FOZK201075
May 21, 2025Becton Dickinson Infusion Therapy Systems, Inc.
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Te
Open, Classified
FOZK220584
Mar 19, 2025B Braun Medical Inc
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Open, Classified
FOZK111236
K182870 +1
Jul 31, 2024Becton Dickinson Infusion Therapy Systems, Inc.
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be i
Open, Classified
FOZK201075
Nov 24, 2023Becton Dickinson Infusion Therapy Systems Inc.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Open, Classified
FOZK201075
Oct 5, 2023ARROW INTERNATIONAL Inc.
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Open, Classified
FOZK071538
Oct 5, 2023ARROW INTERNATIONAL Inc.
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Open, Classified
FOZK071538
Oct 3, 2023Becton Dickinson Infusion Therapy Systems Inc.
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Open, Classified
FOZK220584
Jun 21, 2023ARROW INTERNATIONAL Inc.
ARROW Endurance Extended Dwell Peripheral Catheter System
Open, Classified
FOZK163513
Feb 22, 2023Access Vascular, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Open, Classified
FOZK203069
Feb 22, 2023Access Vascular, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Open, Classified
FOZK203069
Feb 10, 2023Access Vascular, Inc
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Open, Classified
FOZK193015
Feb 10, 2023Access Vascular, Inc
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Open, Classified
FOZK193015
Feb 10, 2023Access Vascular, Inc
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Open, Classified
FOZK203069
Dec 10, 2022ARROW INTERNATIONAL Inc.
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-
Terminated
FOZK002507
K071538
Dec 10, 2022ARROW INTERNATIONAL Inc.
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Terminated
FOZK002507
K071538
Nov 3, 2022Becton Dickinson Infusion Therapy Systems Inc.
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Open, Classified
FOZK183399
Oct 6, 2022B Braun Medical Inc
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Open, Classified
FOZK020785
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
Open, Classified
FOZK071538
Jun 27, 2022ARROW INTERNATIONAL Inc.
Arrow Three-Lumen CVC
Terminated
FOZK970864
Sep 8, 2021Becton Dickinson Infusion Therapy Systems Inc.
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD
Open, Classified
FOZK183399
Jun 21, 2021Delta Med SpA
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Open, Classified
FOZK200373
Jun 21, 2021Delta Med SpA
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Open, Classified
FOZK121007
Jun 21, 2021Delta Med SpA
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Open, Classified
FOZK171530
Jun 21, 2021Delta Med SpA
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832
Open, Classified
FOZK171530
Jun 21, 2021Delta Med SpA
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Open, Classified
FOZK200373
Jun 21, 2021Delta Med SpA
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Open, Classified
FOZK171530
Jan 6, 2021Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Terminated
FOZK993691
Nov 30, 2020Janus Trade Group
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
Terminated
FOZNone listed
Sep 14, 2020Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short te
Terminated
FOZK183399
Sep 4, 2020Braxton Medical Corporation
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and
Open, Classified
FOZNone listed

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