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)
Top companies in FOZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A Open, Classified |
FOZ | K071538 |
| Apr 22, 2026 | ARROW 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 |
FOZ | K071538 |
| Apr 6, 2026 | Cook 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 |
FOZ | K081113 |
| Apr 6, 2026 | Cook 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 |
FOZ | K033843 K081113 |
| Apr 6, 2026 | Cook 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 |
FOZ | K081113 |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A Open, Classified |
FOZ | None listed |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| Jun 23, 2025 | Becton 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 |
FOZ | K201075 |
| May 21, 2025 | Becton 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 |
FOZ | K220584 |
| Mar 19, 2025 | B Braun Medical Inc Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. Open, Classified |
FOZ | K111236 K182870 +1 |
| Jul 31, 2024 | Becton 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 |
FOZ | K201075 |
| Nov 24, 2023 | Becton Dickinson Infusion Therapy Systems Inc. BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 Open, Classified |
FOZ | K201075 |
| Oct 5, 2023 | ARROW 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 |
FOZ | K071538 |
| Oct 5, 2023 | ARROW 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 |
FOZ | K071538 |
| Oct 3, 2023 | Becton 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 |
FOZ | K220584 |
| Jun 21, 2023 | ARROW INTERNATIONAL Inc. ARROW Endurance Extended Dwell Peripheral Catheter System Open, Classified |
FOZ | K163513 |
| Feb 22, 2023 | Access 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 |
FOZ | K203069 |
| Feb 22, 2023 | Access 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 |
FOZ | K203069 |
| Feb 10, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Open, Classified |
FOZ | K193015 |
| Feb 10, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Open, Classified |
FOZ | K193015 |
| Feb 10, 2023 | Access Vascular, Inc HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Open, Classified |
FOZ | K203069 |
| Dec 10, 2022 | ARROW 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 |
FOZ | K002507 K071538 |
| Dec 10, 2022 | ARROW 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 |
FOZ | K002507 K071538 |
| Nov 3, 2022 | Becton 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 |
FOZ | K183399 |
| Oct 6, 2022 | B 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 |
FOZ | K020785 |
| Aug 26, 2022 | Mckesson 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 |
FOZ | K071538 |
| Jun 27, 2022 | ARROW INTERNATIONAL Inc. Arrow Three-Lumen CVC Terminated |
FOZ | K970864 |
| Sep 8, 2021 | Becton 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 |
FOZ | K183399 |
| Jun 21, 2021 | Delta Med SpA WOLF-PAK Self Safe Safety IV Catheter:
a) REF PIVD2010W
b) REF PIV2210W
c) REF PIV2475W Open, Classified |
FOZ | K200373 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter: Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter:
a) REF 3738522
b) REF 3738822 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe T, I.V. catheter of PUR
a) REF 3779422
b) REF 3769522
c) REF 3708522 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe 1, I.V. Catheter with PUR
REF 3708122, Lot 00A1160627
5000 units Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe, I.V. Catheter
REF 3738222 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta 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 |
FOZ | K171530 |
| Jun 21, 2021 | Delta 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 |
FOZ | K171530 |
| Jun 21, 2021 | Delta 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 |
FOZ | K200373 |
| Jun 21, 2021 | Delta 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 |
FOZ | K171530 |
| Jan 6, 2021 | Arrow 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 |
FOZ | K993691 |
| Nov 30, 2020 | Janus 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 |
FOZ | None listed |
| Sep 14, 2020 | Becton 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 |
FOZ | K183399 |
| Sep 4, 2020 | Braxton 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 |
FOZ | None listed |
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