K951448

Substantially Equivalent

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

Applicant: Global Medical Products, Ltd.
Product code: DRC
Advisory panel: Cardiovascular
Date received: 1995-03-29
Decision date: 1996-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Road Town, Tortola, VG

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.