510(k) K990504

MEMOTHERM COLORECTAL STENT by C.R. Bard, Inc. — Product Code MQR

K990504 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "MEMOTHERM COLORECTAL STENT". The FDA issued a decision of Substantially Equivalent on March 16, 2000. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2000
Date Received
February 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Colonic, Metallic, Expandable
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type