EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET— 510(k) K980504

Substantially Equivalent

Schneider/Namic

FDA 510(k) clearance K980504 for EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET, Substantially Equivalent on 1998-08-07. Applicant: Schneider/Namic.

Clearance details

Applicant: Schneider/Namic
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1998-02-09
Decision date: 1998-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.