510(k) K981413

SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS by Boston Scientific Scimed, Inc. — Product Code DQY

K981413 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS". The FDA issued a decision of Substantially Equivalent on May 13, 1998. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1998
Date Received
April 20, 1998
Clearance Type
Special
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