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510(k) Data Aggregation
K Number
K101189Device Name
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
Manufacturer
REAVILLMED
Date Cleared
2010-12-22
(238 days)
Product Code
DRS, LJS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
REAVILLMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
Device Description
The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:
- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap
The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.
The product is sold sterile, single use, and non-pyrogenic.
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