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FDA 510(k)

Vascette HP (hemostatic pad)

K-Number: K220566 · 2022-07-29

ApplicantKoag, LLC
Decision Date2022-07-29
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Vascette HP (hemostatic pad) is the device name listed in this FDA 510(k) record. The listed applicant is Koag, LLC. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220566. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vascette HP (hemostatic pad)?

Vascette HP (hemostatic pad) is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Koag, LLC. The 510(k) number is K220566.

When did Vascette HP (hemostatic pad) receive FDA 510(k) clearance?

Vascette HP (hemostatic pad) received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220566.

Who is the listed applicant for Vascette HP (hemostatic pad)?

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

What is the FDA product code for Vascette HP (hemostatic pad)?

The FDA product code for Vascette HP (hemostatic pad) is QSY.

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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