510(k) K872182

POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE by Polystan C/O Vitalcor, Inc. — Product Code DQY

K872182 is an FDA 510(k) premarket notification submitted by Polystan C/O Vitalcor, Inc. for the device "POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE". The FDA issued a decision of Substantially Equivalent on October 30, 1987. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Polystan C/O Vitalcor, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
June 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type