Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015

K-Number: K083190 · 2008-11-12

ApplicantVascular Solutions, Inc.
Decision Date2008-11-12
Product CodeQSX
DecisionSubstantially Equivalent

Device Summary

D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2008-11-12 under 510(k) number K083190. The device is classified under product code QSX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015?

D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 is a medical device that received FDA 510(k) clearance on 2008-11-12. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K083190.

When did D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 receive FDA 510(k) clearance?

D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 received FDA 510(k) clearance on 2008-11-12, under 510(k) number K083190.

Who is the listed applicant for D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015?

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

What is the FDA product code for D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015?

The FDA product code for D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 is QSX.

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 Vascular Solutions, 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.

K182232Octane Mechanical Thrombectomy SystemK181647Bandit guidewireK180913VSI Micro-Introducer KitK180088TrapLiner catheterK180128Warrior 14 guidewireK173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

View all 96 devices →

Related Devices (Code: QSX)

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.

K200720D-Stat Radial Topical HemostatVascular Solutions, LLCK102212D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVERVascular Solutions, Inc.K092612D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505Vascular Solutions, Inc.K073264D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005Vascular Solutions, Inc.K072117THROMBIX PATCH THROMBIN HEMOSTASIS PATCHVascular Solutions, Inc.K070938THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTATVascular Solutions, 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.

↑