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FDA 510(k)

QuikClot Radial

K-Number: K181641 · 2018-12-24

ApplicantZ-Medica, LLC
Decision Date2018-12-24
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

QuikClot Radial is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica, LLC. It received FDA 510(k) clearance on 2018-12-24 under 510(k) number K181641. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuikClot Radial?

QuikClot Radial is a medical device that received FDA 510(k) clearance on 2018-12-24. The listed applicant is Z-Medica, LLC. The 510(k) number is K181641.

When did QuikClot Radial receive FDA 510(k) clearance?

QuikClot Radial received FDA 510(k) clearance on 2018-12-24, under 510(k) number K181641.

Who is the listed applicant for QuikClot Radial?

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

What is the FDA product code for QuikClot Radial?

The FDA product code for QuikClot Radial is QSY.

Other records listing Z-Medica, LLC 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.

K220971QuikClot Control+ Hemostatic DressingK200167QuikClot Control+

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

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

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