510(k) K911099

MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE by Pilling Co. — Product Code DWX

K911099 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE". The FDA issued a decision of Substantially Equivalent on June 25, 1991. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1991
Date Received
March 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type