510(k) K883313

PMT VASCULAR CATHETER MODEL NUMBER 3621-1 by Pmt Corp. — Product Code LJS

K883313 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT VASCULAR CATHETER MODEL NUMBER 3621-1". The FDA issued a decision of Substantially Equivalent on October 4, 1988. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1988
Date Received
August 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type