MYOWIRE-ATEMPORARY CARDIAC PACING WIRE— 510(k) K803086

Substantially Equivalent

Craig & Craig, Inc.

FDA 510(k) clearance K803086 for MYOWIRE-ATEMPORARY CARDIAC PACING WIRE, Substantially Equivalent on 1981-07-01. Applicant: Craig & Craig, Inc..

Clearance details

Applicant: Craig & Craig, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1980-12-08
Decision date: 1981-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.