Carapace Angiography Trays

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

510(k) Number

K931629 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Various Disposable Kits/Trays/Instru

  Class I

  FDA 510(k) K840976 Active Cleared 31 May 1984

• Carapace Sterile Cotton Balls

  Class I

  FDA 510(k) K931626 Active Cleared 2 Dec 1993

• Surgical Face Mask

  Class II

  FDA 510(k) K790970 Active Cleared 3 Jul 1979

• Carapace Sterile Gauze Trays

  Class II

  FDA 510(k) K931759 Active Cleared 25 Jan 1994

• Carapace Packing Gauze Trays

  Class II

  FDA 510(k) K931760 Active Cleared 4 Feb 1994

• Carapace Instrumlent and Instrument Sets

  Class II

  FDA 510(k) K931824 Active Cleared 6 Dec 1993

See all devices from Carapace, Inc. →

• What types of procedures are the Carapace Angiography Trays designed to support in a catheterization lab?

  The Carapace Angiography Trays are specifically designed to organize and provide access to essential instruments and supplies for diagnostic and interventional cardiovascular imaging, including catheter-based interventions. This includes procedures like coronary angiography, peripheral angiography, and other angiographic studies where structured access to tools is critical.

• Are the Carapace Angiography Trays meant for single-use or can they be reused?

  The Carapace Angiography Trays are sterile and intended for single-use only. This design ensures patient safety and reduces the risk of contamination between procedures, which is particularly important in sterile environments like catheterization labs.

• How are the Carapace Angiography Trays packaged and stored before use?

  The trays come in sterile packaging, which maintains their sterility until opened for use. They should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve their integrity and readiness for sterile procedure setups.

• What regulatory pathway was followed for FDA clearance of these trays?

  The Carapace Angiography Trays were cleared by the FDA through a Traditional 510(k) pathway under the product code DQO, with a decision date of December 6, 1993. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device.