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510(k) Data Aggregation
K Number
K122661Device Name
VITAL 5 RELEAF CATHETER
Manufacturer
VITAL 5
Date Cleared
2013-02-27
(180 days)
Product Code
BSO, GCY, PRE
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
VITAL 5
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
Device Description
The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.
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