GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE— 510(k) K951448

Substantially Equivalent

Global Medical Products, Ltd.

FDA 510(k) clearance K951448 for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE, Substantially Equivalent on 1996-03-27. Applicant: Global Medical Products, Ltd..

Clearance details

Applicant: Global Medical Products, Ltd.
Product code: 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

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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.