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QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.

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Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package.

QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions.

QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy.

This device is intended for temporary external use to control traumatic bleeding.

QuikClot 1st Response™ and QuikClot ACS+™ are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy.

QuikClot ACS - "Advanced Clotting Sponge" ™, is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

The new mesh bags containing beads of QuikClot® Brand Hemostatic Agent, also called QuikClot ACS™ - "Advanced Clotting Sponge", are intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The beads inside the mesh bags consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion. Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation. Used in conjunction with direct pressure, QuikClot ACS™ reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds. This application for Special 510(k) clearance concerns the same hemostatic agent, in bead form, but the beads have been placed inside a synthetic mesh bag in order to facilitate easier application and removal of the product. This device modification retains the benefits of the previous device modification, granules vs. beads, but instead of removing individual beads from a wound medical personnel only need to remove the mesh bag containing the beads.

QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion. Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation. Used in conjunction with direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.