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FDA 510(k)

GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING

K-Number: K121485 · 2012-08-21

ApplicantHemcon Medical Technologies Europe, Ltd.
Decision Date2012-08-21
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hemcon Medical Technologies Europe, Ltd.. It received FDA 510(k) clearance on 2012-08-21 under 510(k) number K121485. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING?

GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING is a medical device that received FDA 510(k) clearance on 2012-08-21. The listed applicant is Hemcon Medical Technologies Europe, Ltd.. The 510(k) number is K121485.

When did GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING receive FDA 510(k) clearance?

GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING received FDA 510(k) clearance on 2012-08-21, under 510(k) number K121485.

Who is the listed applicant for GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING?

The FDA 510(k) record lists Hemcon Medical Technologies Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING?

The FDA product code for GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING is QSY.

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Other records listing Hemcon Medical Technologies Europe, Ltd. 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.

K112215HEMCON HEMOSTATIC GELK093729GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I

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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