FDA 510(k)

Interject Injection Therapy Needle Catheter

K-Number: K171454 · 2017-07-07

Decision Date2017-07-07

Product CodeFBK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Interject Injection Therapy Needle Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K171454. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Interject Injection Therapy Needle Catheter?

Interject Injection Therapy Needle Catheter is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Boston Scientific Corporation. The 510(k) number is K171454.

When did Interject Injection Therapy Needle Catheter receive FDA 510(k) clearance?

Interject Injection Therapy Needle Catheter received FDA 510(k) clearance on 2017-07-07, under 510(k) number K171454.

Who is the listed applicant for Interject Injection Therapy Needle Catheter?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Interject Injection Therapy Needle Catheter?

The FDA product code for Interject Injection Therapy Needle Catheter is FBK.

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Related Devices (Code: FBK)

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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.