Cleared Traditional

BL-Cart IOL Delivery Cartridge

K182965 · Ast Products, Inc. · Ophthalmic

Mar 2019

Decision

155d

Days

Class 1

Risk

About This 510(k) Submission

K182965 is an FDA 510(k) clearance for the BL-Cart IOL Delivery Cartridge, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Ast Products, Inc. (Billerica, US). The FDA issued a Cleared decision on March 29, 2019, 155 days after receiving the submission on October 25, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K182965 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2018
Decision Date	March 29, 2019
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF