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FDA 510(k)

D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505

K-Number: K092612 · 2009-09-11

ApplicantVascular Solutions, Inc.
Decision Date2009-09-11
Product CodeQSX
DecisionSubstantially Equivalent

Device Summary

D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 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 2009-09-11 under 510(k) number K092612. The device is classified under product code QSX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505?

D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 is a medical device that received FDA 510(k) clearance on 2009-09-11. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K092612.

When did D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 receive FDA 510(k) clearance?

D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 received FDA 510(k) clearance on 2009-09-11, under 510(k) number K092612.

Who is the listed applicant for D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505?

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 RAD-BAND, RAD-BAND, MODELS 3501, 3505?

The FDA product code for D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 is QSX.

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Other records listing Vascular Solutions, Inc. as applicant

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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.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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