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FDA 510(k)

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5

K-Number: K022117 · 2002-10-11

ApplicantMerit Medical Systems, Inc.
Decision Date2002-10-11
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 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 2002-10-11 under 510(k) number K022117. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5?

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K022117.

When did MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 receive FDA 510(k) clearance?

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022117.

Who is the listed applicant for MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5?

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 MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5?

The FDA product code for MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 is DRC.

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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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