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Monitor Input Cable, Mikro-Cath to EP-Tracer System
MILLAR INC. · Model 850-5148 · UDI-DI 00868924000267
DRQ
Prescription
10
510(k) clearances
51
Adverse events
1
Recalls
36
Facilities
Description
The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Cardiotek GmbH medical device as detailed below: EP-Tracer 38, EP-Tracer 70, EP-Tracer 102, when used with the following system configurations: EP-Tracer Portable, EP-Tracer Stationary, EP-Tracer ProCart. The 850-5148 cable is 10 feet long. The cable is supplied nonsterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-02 | Boston Scientific Corporation | Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels b |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.