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FDA 510(k)

D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER

K-Number: K102212 · 2011-04-08

ApplicantVascular Solutions, Inc.
Decision Date2011-04-08
Product CodeQSX
DecisionSubstantially Equivalent

Device Summary

D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER 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 2011-04-08 under 510(k) number K102212. The device is classified under product code QSX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER?

D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K102212.

When did D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER receive FDA 510(k) clearance?

D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER received FDA 510(k) clearance on 2011-04-08, under 510(k) number K102212.

Who is the listed applicant for D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER?

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 SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER?

The FDA product code for D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER is QSX.

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Other records listing Vascular Solutions, Inc. as applicant

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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, LLCK092612D-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.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.

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