Atlas FDA

ARTERIAL LINE KIT

FDA 510(k) clearance K780871 · decided 1978-06-14

Clearance details

K-number
K780871
Device name
ARTERIAL LINE KIT
Applicant
Argon Medical Corp.
Decision
Substantially Equivalent
Date received
1978-05-30
Decision date
1978-06-14
Days to decision
15 days
Clearance type
Traditional
Product code
GDY
Device class
1
Regulation number
878.4450
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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CYLINDRICAL SPONGE (K953057)Medical Perspectives Corp.1995-09-14
ROUND STICK SPONGES, FLAT STICK SPONGES (K953058)Medical Perspectives Corp.1995-09-14
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CHERRY DISSECTOR (K953062)Medical Perspectives Corp.1995-09-14

Recalls involving this device

RecordFirmDate
Arterial Line Kit 20ga x 6, REF: 400115A recall (Z-2708-2026)Argon Medical Devices, Inc2026-07-10
ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, R recall (Z-1737-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, recall (Z-1740-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Device recall (Z-1741-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices recall (Z-1742-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices recall (Z-1743-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon recall (Z-1744-2010)Argon Medical Devices, Inc2010-06-02
ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. A recall (Z-1745-2010)Argon Medical Devices, Inc2010-06-02