Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BL-Cart IOL Delivery Cartridge

K-Number: K182965 · 2019-03-29

ApplicantAst Products, Inc.
Decision Date2019-03-29
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BL-Cart IOL Delivery Cartridge is a medical device manufactured by Ast Products, Inc.. It received FDA 510(k) clearance on 2019-03-29 under approval number K182965. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BL-Cart IOL Delivery Cartridge?

BL-Cart IOL Delivery Cartridge is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Ast Products, Inc.. The 510(k) number is K182965.

When was BL-Cart IOL Delivery Cartridge approved by the FDA?

BL-Cart IOL Delivery Cartridge received FDA 510(k) clearance on 2019-03-29, under approval number K182965.

What company makes BL-Cart IOL Delivery Cartridge?

BL-Cart IOL Delivery Cartridge is manufactured by Ast Products, Inc..

What is the FDA product code for BL-Cart IOL Delivery Cartridge?

The FDA product code for BL-Cart IOL Delivery Cartridge is MSS.

Related Clinical Trials

NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Other Devices by Ast Products, Inc.

K172228pioli IOL Delivery System K200057bioli lOL Delivery System

Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑