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FDA 510(k)

VacLok AT Vacuum Syringe

K-Number: K163597 · 2017-07-27

ApplicantMerit Medical Systems, Inc.
Decision Date2017-07-27
Product CodePUR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VacLok AT Vacuum Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K163597. The device is classified under product code PUR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VacLok AT Vacuum Syringe?

VacLok AT Vacuum Syringe is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K163597.

When did VacLok AT Vacuum Syringe receive FDA 510(k) clearance?

VacLok AT Vacuum Syringe received FDA 510(k) clearance on 2017-07-27, under 510(k) number K163597.

Who is the listed applicant for VacLok AT Vacuum Syringe?

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

What is the FDA product code for VacLok AT Vacuum Syringe?

The FDA product code for VacLok AT Vacuum Syringe is PUR.

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Related Devices (Code: PUR)

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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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