DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Craig & Craig, Inc.
Product code
Code LDF
Device class
Class 2
Regulation
21 CFR 870.3680
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LDF

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Adverse events under product code LDF

product code LDF
Death
19
Injury
188
Malfunction
694
Other
1
Total
902

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K803086

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K803086.

Data sourced from openFDA. This site is unofficial and independent of the FDA.