ClearanceBrief
510(k) K780532 ยท DYB Introducer, Catheter

PERCUTANEOUS SHEATH INTRODUCER KIT

ApplicantArrow Intl., Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Apr 21, 1978
ReceivedApr 4, 1978
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K780532

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10
Open, Classified
DYBNone listed
Dec 20, 2019Arrow International Inc
Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Terminated
DYBNone listed
May 23, 2018Arrow International Inc
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous ac
Terminated
DYBNone listed
Apr 11, 2018Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
Terminated
DYBNone listed
Apr 11, 2018Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
Terminated
DYBNone listed
Apr 11, 2018Arrow International Inc
Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
Terminated
DYBNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
Terminated
DYBNone listed
Apr 11, 2018Arrow International Inc
9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
Terminated
DYBNone listed
Mar 5, 2018Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and cathe
Terminated
DYBNone listed
Dec 22, 2017Arrow International Inc
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1
Terminated
DYBNone listed
Oct 26, 2017Arrow International Inc
Arterial Access Tray, introducer catheter; Model: GU-04020
Terminated
DYBNone listed
May 9, 2017Arrow International Inc
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Terminated
DYBNone listed
Oct 14, 2014Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Terminated
DQYNone listed
Jun 4, 2014Arrow International Inc
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Terminated
DYBNone listed
Dec 9, 2013Arrow International Inc
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Terminated
DYBNone listed
Mar 25, 2011Arrow International Inc
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
Terminated
DYBNone listed
Jan 21, 2011Arrow International Inc
Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and
Terminated
DYBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.