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FDA 510(k)

INTERVENTIONAL HEMOSTATIC BANDAGE

K-Number: K120782 · 2013-03-20

ApplicantZ-Medica Corporation
Decision Date2013-03-20
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

INTERVENTIONAL HEMOSTATIC BANDAGE 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 2013-03-20 under 510(k) number K120782. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERVENTIONAL HEMOSTATIC BANDAGE?

INTERVENTIONAL HEMOSTATIC BANDAGE is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is Z-Medica Corporation. The 510(k) number is K120782.

When did INTERVENTIONAL HEMOSTATIC BANDAGE receive FDA 510(k) clearance?

INTERVENTIONAL HEMOSTATIC BANDAGE received FDA 510(k) clearance on 2013-03-20, under 510(k) number K120782.

Who is the listed applicant for INTERVENTIONAL HEMOSTATIC BANDAGE?

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 INTERVENTIONAL HEMOSTATIC BANDAGE?

The FDA product code for INTERVENTIONAL HEMOSTATIC BANDAGE is QSY.

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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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