510(k) K940073

EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30 by Puritas Health Care, Inc. — Product Code FPA

K940073 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
January 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type