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FDA 510(k)

CLO-SURPLUS P.A.D.

K-Number: K112961 · 2011-10-31

ApplicantScion Cardio-Vascular, Inc.
Decision Date2011-10-31
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

CLO-SURPLUS P.A.D. is the device name listed in this FDA 510(k) record. The listed applicant is Scion Cardio-Vascular, Inc.. It received FDA 510(k) clearance on 2011-10-31 under 510(k) number K112961. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLO-SURPLUS P.A.D.?

CLO-SURPLUS P.A.D. is a medical device that received FDA 510(k) clearance on 2011-10-31. The listed applicant is Scion Cardio-Vascular, Inc.. The 510(k) number is K112961.

When did CLO-SURPLUS P.A.D. receive FDA 510(k) clearance?

CLO-SURPLUS P.A.D. received FDA 510(k) clearance on 2011-10-31, under 510(k) number K112961.

Who is the listed applicant for CLO-SURPLUS P.A.D.?

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

What is the FDA product code for CLO-SURPLUS P.A.D.?

The FDA product code for CLO-SURPLUS P.A.D. 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 Scion Cardio-Vascular, 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.

K092552CLO-SURPLUS P.A.D.K052509M-BOLUS EMBOLIC MICROSPHERESK032986CLO-SURPLUSP.A.D.

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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