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FDA 510(k)

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

K-Number: K172929 · 2018-01-10

ApplicantBoston Scientific Corporation
Decision Date2018-01-10
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-01-10 under approval number K172929. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath?

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K172929.

When was Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath approved by the FDA?

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath received FDA 510(k) clearance on 2018-01-10, under approval number K172929.

What company makes Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath?

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath is manufactured by Boston Scientific Corporation.

What is the FDA product code for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath?

The FDA product code for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath is LJE.

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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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