CG+ ARROW JACC POWERED BY ARROW VPS STYLET— 510(k) K132133
Substantially EquivalentArrow International (Subsidiary of Teleflex Inc.)
FDA 510(k) clearance K132133 for CG+ ARROW JACC POWERED BY ARROW VPS STYLET, Substantially Equivalent on 2013-09-26. Applicant: Arrow International (Subsidiary of Teleflex Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International (Subsidiary of Teleflex Inc.)
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reading, PA, US
Recent devices under product code OBJ
view allMore clearances from Arrow International (Subsidiary of Teleflex Inc.)
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K132133
K-number listed on FDA's recall record- Z-2379-2026 — 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 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A
- Z-1806-2019 — Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
- Z-1812-2019 — Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
- Z-1814-2019 — Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
- Z-1815-2019 — Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
- Z-1816-2019 — Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
- Z-1817-2019 — Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
- Z-2015-2018 — ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
- Z-0207-2016 — 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 Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132133.
Data sourced from openFDA. This site is unofficial and independent of the FDA.