510(k) K971137

BARD RAPIDFIRE MULTIPLE BAND LIGATOR by C.R. Bard, Inc. — Product Code MND

K971137 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD RAPIDFIRE MULTIPLE BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
March 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type