510(k) K112896 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARRW EVOLUTION
| Applicant | Arrow International (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, May 10, 2012 |
| Received | Sep 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC;
AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB;
AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV;
AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DL Open, Classified |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC
Product Code: CDC45541HPK1A Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code: PR 45541 HPHNL Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code:PR 45541 HPHNM Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
Product Code:PR 45552 HPHNM Terminated |
LJS | None listed |
| Dec 22, 2017 | Arrow International Inc Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4 Terminated |
JLS | None listed |
| Nov 27, 2017 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC
Kit with Chlorag+ard(R) Technology
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) centra Terminated |
LJS | None listed |
| Jun 27, 2017 | Arrow International Inc Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology Terminated |
LJS | None listed |
| May 9, 2017 | Arrow International Inc 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long Terminated |
LJS | None listed |
| Mar 8, 2017 | Arrow International Inc The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein. Terminated |
LJS | 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.