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FDA 510(k)

HEMADERM COTAINING HEMADEX CLOTTING BEADS

K-Number: K021678 · 2002-07-12

ApplicantMedafor, Inc.
Decision Date2002-07-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

HEMADERM COTAINING HEMADEX CLOTTING BEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medafor, Inc.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021678. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMADERM COTAINING HEMADEX CLOTTING BEADS?

HEMADERM COTAINING HEMADEX CLOTTING BEADS is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Medafor, Inc.. The 510(k) number is K021678.

When did HEMADERM COTAINING HEMADEX CLOTTING BEADS receive FDA 510(k) clearance?

HEMADERM COTAINING HEMADEX CLOTTING BEADS received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021678.

Who is the listed applicant for HEMADERM COTAINING HEMADEX CLOTTING BEADS?

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

What is the FDA product code for HEMADERM COTAINING HEMADEX CLOTTING BEADS?

The FDA product code for HEMADERM COTAINING HEMADEX CLOTTING BEADS is QSY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medafor, Inc. 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.

K123325Medafor Direct Gas-Assisted Application SystemK033666HEMADERMK013225INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

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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