510(k) K780532 ยท DYB Introducer, Catheter
PERCUTANEOUS SHEATH INTRODUCER KIT
| Applicant | Arrow Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 21, 1978 |
| Received | Apr 4, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW 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 |
DYB | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters
ASK-09801-UPM Terminated |
DYB | None listed |
| May 23, 2018 | Arrow 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 |
DYB | None listed |
| Apr 11, 2018 | Arrow 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 |
DYB | None listed |
| Apr 11, 2018 | Arrow 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 |
DYB | None listed |
| Apr 11, 2018 | Arrow International Inc Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 Terminated |
DYB | None listed |
| Apr 11, 2018 | Arrow 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 |
DYB | None listed |
| Apr 11, 2018 | Arrow 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 |
DYB | None listed |
| Mar 5, 2018 | Arrow 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 |
DYB | None listed |
| Dec 22, 2017 | Arrow 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 |
DYB | None listed |
| Oct 26, 2017 | Arrow International Inc Arterial Access Tray, introducer catheter; Model: GU-04020 Terminated |
DYB | None listed |
| May 9, 2017 | Arrow 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 |
DYB | None listed |
| Oct 14, 2014 | Arrow International Inc Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. Terminated |
DQY | None listed |
| Jun 4, 2014 | Arrow 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 |
DYB | None listed |
| Dec 9, 2013 | Arrow 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 |
DYB | None listed |
| Mar 25, 2011 | Arrow International Inc Percutaneous Sheath Introducer Kit
Intended usage: Permits venous access and catheter introduction to the central circulation system Terminated |
DYB | None listed |
| Jan 21, 2011 | Arrow 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 |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.