510(k) K934988

9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER by Scimed Life Systems, Inc. — Product Code DQY

K934988 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on Jan 14, 1994. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 14, 1994
Date Received
Oct 18, 1993
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
510(k)

Source: FDA 510(k) database entry for K934988. Report a data issue: hello@regdatalab.com.