510(k) K820009 ยท DQY Catheter, Percutaneous
ARROW JUGULAR PUNCTURE KIT 16 GA.
| Applicant | Arrow Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 22, 1982 |
| Received | Jan 5, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6
RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP
ACCESS TRAY/ASK-04001-MS
RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1
VESSEL CATH KIT: 20GA X 5 Open, Classified |
DQY | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow Central Venous Catheterization Kit
ASK-04200-UPM Terminated |
DQY | None listed |
| Apr 11, 2018 | Arrow International Inc Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ Terminated |
DQY | None listed |
| Dec 22, 2017 | Arrow International Inc (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterizatio Terminated |
DQY | None listed |
| May 9, 2017 | Arrow International Inc Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous
The Arrow Single-Lumen Catheter permits venous access to the central circulation Terminated |
DQY | None listed |
| Feb 17, 2011 | Arrow International Inc INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050
Internal jugular puncture kit Terminated |
DQY | None listed |
| Feb 17, 2011 | Arrow International Inc PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E
Pediatric jugular puncture kit Terminated |
DQY | None listed |
| Feb 17, 2011 | Arrow International Inc VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG.
Vessel catheterization kit Terminated |
DQY | None listed |
| Feb 17, 2011 | Arrow International Inc CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660.
Central venous catheterization kit Terminated |
DQY | None listed |
| Feb 17, 2011 | Arrow International Inc JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800.
Jugular puncture kit Terminated |
DQY | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Single Lumen CVCs (Central Venous Catheters) Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.