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FDA 510(k)

PRO QR ADVANCED FORMULA POWDER

K-Number: K080210 · 2009-02-10

ApplicantBiolife, LLC
Decision Date2009-02-10
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

PRO QR ADVANCED FORMULA POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Biolife, LLC. It received FDA 510(k) clearance on 2009-02-10 under 510(k) number K080210. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO QR ADVANCED FORMULA POWDER?

PRO QR ADVANCED FORMULA POWDER is a medical device that received FDA 510(k) clearance on 2009-02-10. The listed applicant is Biolife, LLC. The 510(k) number is K080210.

When did PRO QR ADVANCED FORMULA POWDER receive FDA 510(k) clearance?

PRO QR ADVANCED FORMULA POWDER received FDA 510(k) clearance on 2009-02-10, under 510(k) number K080210.

Who is the listed applicant for PRO QR ADVANCED FORMULA POWDER?

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

What is the FDA product code for PRO QR ADVANCED FORMULA POWDER?

The FDA product code for PRO QR ADVANCED FORMULA POWDER 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 Biolife, LLC 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.

K130324STATSEAL DISCK070520PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)

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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