MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5— 510(k) K022117

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K022117 for MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5, Substantially Equivalent on 2002-10-11. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2002-07-01
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.