MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS— 510(k) K150319

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K150319 for MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS, Substantially Equivalent on 2015-06-12. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2015-02-09
Decision date: 2015-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.