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 4, 2020 | Angiodynamics, 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 |
FOZ | None listed |
| May 4, 2020 | Angiodynamics, 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 |
FOZ | None listed |
| Mar 6, 2020 | Cook Inc. Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053 Terminated |
FOZ | K033843 |
| Dec 6, 2019 | Arrow International Inc Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH Terminated |
FOZ | K163513 |
| Jul 18, 2019 | Arrow 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 |
FOZ | K993691 |
| May 17, 2019 | Arrow 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 |
FOZ | K900263 |
| Mar 1, 2019 | Becton 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 |
FOZ | K161777 |
| Nov 26, 2018 | Smiths Medical ASD Inc. ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton. Terminated |
FOZ | K990236 |
| Sep 21, 2018 | Arrow 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 |
FOZ | K993691 |
| Aug 30, 2018 | Arrow 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 |
FOZ | K993691 |
| Aug 23, 2018 | Becton 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 |
FOZ | K032843 |
| Aug 22, 2018 | Smiths 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 |
FOZ | K160235 |
| Jul 10, 2018 | Arrow 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 |
FOZ | K862056 |
| Jul 10, 2018 | Arrow 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 |
FOZ | K862056 |
| Jul 3, 2018 | Arrow 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 |
FOZ | K900263 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 Terminated |
FOZ | K161866 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810 Terminated |
FOZ | K161866 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490 Terminated |
FOZ | K161866 |
| Apr 11, 2018 | Arrow International Inc ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC Terminated |
FOZ | K993691 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K993691 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K993691 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K993691 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K993691 |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1 Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2 Terminated |
FOZ | K900263 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K900263 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K011761 |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC Terminated |
FOZ | K071538 |
| Apr 11, 2018 | Arrow 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 |
FOZ | K071538 |
| Mar 21, 2018 | Arrow 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 |
FOZ | K993691 |
| Mar 14, 2018 | Arrow International Inc ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B Terminated |
FOZ | K151513 |
| Mar 5, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit.
Intended to permit venous access to the central circulation. Terminated |
FOZ | K071538 |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen CVC Kit Terminated |
FOZ | K071538 |
| Mar 5, 2018 | Arrow 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 |
FOZ | K071538 |
| Mar 5, 2018 | Arrow 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 |
FOZ | K071538 |
| Mar 5, 2018 | Arrow 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 |
FOZ | K071538 |
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