Percutaneous Guidewire Placement Syringe 50505

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K855089 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

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  FDA 510(k) K821149 Active Cleared 18 May 1982

• Clearview Blower/Mister Open recall

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  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

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  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Aortic Root Cannula W/Integral Press

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  FDA 510(k) K831591 Active Cleared 30 Jun 1983

• Code #94315 Retrograde Coronary Sinus Perf Cannula

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  FDA 510(k) K901074 Active Cleared 6 Jul 1990

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• What is the Percutaneous Guidewire Placement Syringe 50505 primarily used for in medical procedures?

  The Percutaneous Guidewire Placement Syringe 50505 is designed to assist in placing guidewires through percutaneous catheters during interventional procedures. It helps navigate guidewires within blood vessels, ensuring precise and controlled placement for procedures like angioplasty or stenting.

• Is this syringe intended for reuse in clinical settings, or is it meant for single-use only?

  The device is explicitly labeled for single-use in clinical settings. This ensures patient safety and sterility, as it is supplied sterile and not intended to be reused after one procedure.

• How is the regulatory status of this syringe determined, and which advisory committee was involved?

  The Percutaneous Guidewire Placement Syringe 50505 received FDA 510(k) clearance under the Cardiovascular advisory committee (CV). It was classified as *substantially equivalent* to a predicate device, meaning its safety and effectiveness were deemed comparable to an already-approved product in the same category (product code DQX).

• What should clinicians consider when storing this syringe before use?

  Since the syringe is supplied sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediate use to maintain sterility and prevent contamination.