510(k) K942154

SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS by Boston Scientific Scimed, Inc. — Product Code LIT

K942154 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS". The FDA issued a decision of Substantially Equivalent on Aug 18, 1994. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Scimed, Inc. has 34 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 18, 1994
Date Received
Apr 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K942154. Report a data issue: hello@regdatalab.com.