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FDA 510(k)

BD Preset Syringe & BD A-Line Syringe

K-Number: K202446 · 2020-09-25

ApplicantBecton, Dickinson and Company
Decision Date2020-09-25
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BD Preset Syringe & BD A-Line Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-09-25 under approval number K202446. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Preset Syringe & BD A-Line Syringe?

BD Preset Syringe & BD A-Line Syringe is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K202446.

When was BD Preset Syringe & BD A-Line Syringe approved by the FDA?

BD Preset Syringe & BD A-Line Syringe received FDA 510(k) clearance on 2020-09-25, under approval number K202446.

What company makes BD Preset Syringe & BD A-Line Syringe?

BD Preset Syringe & BD A-Line Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Preset Syringe & BD A-Line Syringe?

The FDA product code for BD Preset Syringe & BD A-Line Syringe is JKA.

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

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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.

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