510(k) K182965

BL-Cart IOL Delivery Cartridge by Ast Products, Inc. — Product Code MSS

K182965 is an FDA 510(k) premarket notification submitted by Ast Products, Inc. for the device "BL-Cart IOL Delivery Cartridge". The FDA issued a decision of Substantially Equivalent on March 29, 2019. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Ast Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
October 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type