QFJClass II

Intravascular Bleed Monitor

Cardiovascular · 21 CFR 870.1345

An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

MDR events3All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances2All time

Recent MDR events

3 adverse event reports on file

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EARLY BIRD BLEED MONITORING SYSTEMFeb 26, 2023
DeathSaranas, Inc.3016011241-2023-00001
EARLY BIRD BLEED MONITORING SYSTEMFeb 26, 2023
InjurySaranas, Inc.3016011241-2023-00002
EARLY BIRD BLEED MONITORING SYSTEMJan 16, 2023
InjurySaranas, Inc.3016011241-2022-00001

Event type breakdown

Injury2

Death1

Most-reported manufacturers

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Saranas, Inc.3

Recalls

1 recall events for this product code

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Saranas, Inc.
Open, ClassifiedUnknown
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Z-1684-2022 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

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No registered firms found for this product code.

510(k) clearances

2 clearances for this product code

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