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FDA 510(k)

THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT

K-Number: K050511 · 2005-04-14

ApplicantVascular Solutions, Inc.
Decision Date2005-04-14
Product CodeQSX
DecisionSubstantially Equivalent

Device Summary

THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT 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 2005-04-14 under 510(k) number K050511. The device is classified under product code QSX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT?

THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K050511.

When did THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT receive FDA 510(k) clearance?

THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT received FDA 510(k) clearance on 2005-04-14, under 510(k) number K050511.

Who is the listed applicant for THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT?

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 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT?

The FDA product code for THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT is QSX.

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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

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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.K083190D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015Vascular Solutions, Inc.K073264D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005Vascular Solutions, Inc.K072117THROMBIX PATCH THROMBIN HEMOSTASIS PATCHVascular 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.

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