510(k) K940079 ยท DYB Introducer, Catheter
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Nov 30, 1994 |
| Received | Jan 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940079
| 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 |
| Apr 11, 2018 | Arrow International Inc Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters
; Product Codes: ASK-09903-UM Terminated |
DYB | None listed |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Prod Terminated |
DYB | None listed |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath
and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS Terminated |
DYB | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: MSO-45703-AHS Terminated |
DYB | None listed |
| Mar 5, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters.
Permit Terminated |
DYB | None listed |
| Dec 22, 2017 | Arrow International Inc Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD Terminated |
DYB | None listed |
| Mar 5, 2010 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The p Terminated |
DYB | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers Terminated |
DYB | None listed |
| Jul 19, 2003 | Arrow International Inc 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.