ARTERIAL LINE KIT— 510(k) K780871
Substantially EquivalentArgon Medical Corp.
FDA 510(k) clearance K780871 for ARTERIAL LINE KIT, Substantially Equivalent on 1978-06-14. Applicant: Argon Medical Corp.. Device class: 1.
Clearance details
- Applicant
- Argon Medical Corp.
- Product code
- Code GDY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4450
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GDY
view allMore clearances from Argon Medical Corp.
view allAdverse events under product code GDY
product code GDY- Malfunction
- 764
- Total
- 764
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 K780871
K-number listed on FDA's recall record- Z-2708-2026 — Arterial Line Kit 20ga x 6, REF: 400115A
- Z-0563-2022 — 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- Z-1936-2020 — Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS
- Z-1937-2020 — Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit/1 20ga x 3", Qty: 10/CS, CE 2797
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K780871.
Data sourced from openFDA. This site is unofficial and independent of the FDA.