510(k) K132133 ยท OBJ Catheter, Ultrasound, Intravascular
CG+ ARROW JACC POWERED BY ARROW VPS STYLET
| Applicant | Arrow International (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | Jul 11, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC;
PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC;
AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A;
AGBA PI JACC KIT: 2-L 5.5 FR X Open, Classified |
OBJ | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 44052 VPS2 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code: JR 42041 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code: JR 42541 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow JACC with Chlorag+ard Technology
Product Code:JR 42563 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: JRT 43541 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance JACC
Product Code: JRT 43552 HPHNM Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM Terminated |
OBJ | None listed |
| Nov 4, 2015 | Arrow International Inc ARROW PICC Kit featuring Chlorag+ard Technology
Midline Catheterization Kit
ARROW Advantage5 Pressure Injectable PICC Kit
Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet
ARROW Pressur Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.