ClearanceBrief
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 4, 2020Angiodynamics, Inc.
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature
Terminated
FOZNone listed
May 4, 2020Angiodynamics, Inc.
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing
Terminated
FOZNone listed
Mar 6, 2020Cook Inc.
Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
Terminated
FOZK033843
Dec 6, 2019Arrow International Inc
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Terminated
FOZK163513
Jul 18, 2019Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PL
Terminated
FOZK993691
May 17, 2019Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of d
Terminated
FOZK900263
Mar 1, 2019Becton Dickinson & Company
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Terminated
FOZK161777
Nov 26, 2018Smiths Medical ASD Inc.
ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Terminated
FOZK990236
Sep 21, 2018Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to
Terminated
FOZK993691
Aug 30, 2018Arrow International Inc
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requi
Terminated
FOZK993691
Aug 23, 2018Becton Dickinson & Company
BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiv
Terminated
FOZK032843
Aug 22, 2018Smiths Medical ASD Inc.
Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopa
Terminated
FOZK160235
Jul 10, 2018Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous
Terminated
FOZK862056
Jul 10, 2018Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous a
Terminated
FOZK862056
Jul 3, 2018Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central c
Terminated
FOZK900263
May 10, 2018Angiodynamics Inc. (Navilyst Medical Inc.)
RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
Terminated
FOZK161866
May 10, 2018Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Terminated
FOZK161866
May 10, 2018Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
Terminated
FOZK161866
Apr 11, 2018Arrow International Inc
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Terminated
FOZK993691
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-
Terminated
FOZK993691
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
Terminated
FOZK993691
Apr 11, 2018Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
Terminated
FOZK993691
Apr 11, 2018Arrow International Inc
Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
Terminated
FOZK993691
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LD
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
Terminated
FOZK900263
Apr 11, 2018Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
Terminated
FOZK900263
Apr 11, 2018Arrow International Inc
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP
Terminated
FOZK011761
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
Terminated
FOZK071538
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
Terminated
FOZK071538
Mar 21, 2018Arrow International Inc
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral ve
Terminated
FOZK993691
Mar 14, 2018Arrow International Inc
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Terminated
FOZK151513
Mar 5, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
Terminated
FOZK071538
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen CVC Kit
Terminated
FOZK071538
Mar 5, 2018Arrow International Inc
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Terminated
FOZK071538
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to
Terminated
FOZK071538
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Terminated
FOZK071538

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