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FDA 510(k)

Imager II Urology Torque Catheter

K-Number: K180530 · 2018-04-10

ApplicantBoston Scientific Corporation
Decision Date2018-04-10
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Imager II Urology Torque 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 2018-04-10 under 510(k) number K180530. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imager II Urology Torque Catheter?

Imager II Urology Torque Catheter is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K180530.

When did Imager II Urology Torque Catheter receive FDA 510(k) clearance?

Imager II Urology Torque Catheter received FDA 510(k) clearance on 2018-04-10, under 510(k) number K180530.

Who is the listed applicant for Imager II Urology Torque 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 Imager II Urology Torque Catheter?

The FDA product code for Imager II Urology Torque Catheter is KOD.

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Related Devices (Code: KOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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