510(k) K801912 ยท CAZ Anesthesia Conduction Kit
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
| Applicant | Arrow Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 16, 1980 |
| Received | Aug 11, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/ASK-04001-SUH-S;
ACCESS TRAY/ASK-04001-VM1;
STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS;
STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
STIMUCATH SFTY KIT: Open, Classified |
CAZ | None listed |
| Jul 6, 2020 | Arrow International Inc Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space. Terminated |
CAZ | None listed |
| Jan 24, 2020 | Arrow International Inc TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION KIT
AK-05000 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION KIT
YC-02220 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION KIT
JH-05500 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION KIT
AM-05500 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION KIT
CK-02220 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL CATHETERIZATION COMPONENT
EC-05000 Terminated |
CAZ | None listed |
| Apr 11, 2018 | Arrow International Inc TheraCath(R) Epidural Catheter; Product Code: EC-05000 Terminated |
CAZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.