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FDA 510(k)

CORELEADER HEMO-PAD MODEL CPII 02030

K-Number: K102944 · 2011-09-07

ApplicantCoreleader Biotech Co., Ltd.
Decision Date2011-09-07
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

CORELEADER HEMO-PAD MODEL CPII 02030 is the device name listed in this FDA 510(k) record. The listed applicant is Coreleader Biotech Co., Ltd.. It received FDA 510(k) clearance on 2011-09-07 under 510(k) number K102944. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORELEADER HEMO-PAD MODEL CPII 02030?

CORELEADER HEMO-PAD MODEL CPII 02030 is a medical device that received FDA 510(k) clearance on 2011-09-07. The listed applicant is Coreleader Biotech Co., Ltd.. The 510(k) number is K102944.

When did CORELEADER HEMO-PAD MODEL CPII 02030 receive FDA 510(k) clearance?

CORELEADER HEMO-PAD MODEL CPII 02030 received FDA 510(k) clearance on 2011-09-07, under 510(k) number K102944.

Who is the listed applicant for CORELEADER HEMO-PAD MODEL CPII 02030?

The FDA 510(k) record lists Coreleader Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORELEADER HEMO-PAD MODEL CPII 02030?

The FDA product code for CORELEADER HEMO-PAD MODEL CPII 02030 is QSY.

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Other records listing Coreleader Biotech Co., 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.

K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGK111578CORELEADER COLLA-ALGI FIBER MODEL CAWK111733CORELEADER SCAR-DIMMERK102942CORELEADER ALGIPLASTER MODEL AP 050501K102946CORELEADER COLLA-PAD MODEL CS 03030K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

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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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