Search Results
Found 1 results
510(k) Data Aggregation
K Number
K180546Device Name
Jet Power Injectable PICC
Manufacturer
Date Cleared
2018-11-21
(265 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
Jet Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.
Device Description
A family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger Technique).
Ask a Question
Ask a specific question about this device
Page 1 of 1