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FDA 510(k)

HEMOHALT HEMOSTASIS PAD

K-Number: K060409 · 2006-05-17

ApplicantVanson-Halosource, Inc.
Decision Date2006-05-17
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

HEMOHALT HEMOSTASIS PAD is the device name listed in this FDA 510(k) record. The listed applicant is Vanson-Halosource, Inc.. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K060409. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOHALT HEMOSTASIS PAD?

HEMOHALT HEMOSTASIS PAD is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Vanson-Halosource, Inc.. The 510(k) number is K060409.

When did HEMOHALT HEMOSTASIS PAD receive FDA 510(k) clearance?

HEMOHALT HEMOSTASIS PAD received FDA 510(k) clearance on 2006-05-17, under 510(k) number K060409.

Who is the listed applicant for HEMOHALT HEMOSTASIS PAD?

The FDA 510(k) record lists Vanson-Halosource, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOHALT HEMOSTASIS PAD?

The FDA product code for HEMOHALT HEMOSTASIS PAD 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

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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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