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FDA 510(k)

QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER

K-Number: K070010 · 2007-01-25

ApplicantZ-Medica Corporation
Decision Date2007-01-25
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica Corporation. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K070010. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER?

QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Z-Medica Corporation. The 510(k) number is K070010.

When did QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER receive FDA 510(k) clearance?

QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER received FDA 510(k) clearance on 2007-01-25, under 510(k) number K070010.

Who is the listed applicant for QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER?

The FDA 510(k) record lists Z-Medica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER?

The FDA product code for QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER is QSY.

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Other records listing Z-Medica Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120782INTERVENTIONAL HEMOSTATIC BANDAGEK090620QUIKCLOT INTEVENTIONAL, MODEL P/N 182K080247QUIKCLOT NOSEBLEEDK072474QUIKCLOT EXK061767QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+K051955QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE

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Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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