FDA 510(k)

IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1

K-Number: K011965 · 2001-07-13

Decision Date2001-07-13

Product CodeKOD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2001-07-13 under 510(k) number K011965. 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, MODEL 40030X1, 40040X1, AND 40050X1?

IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K011965.

When did IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 receive FDA 510(k) clearance?

IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 received FDA 510(k) clearance on 2001-07-13, under 510(k) number K011965.

Who is the listed applicant for IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1?

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

What is the FDA product code for IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1?

The FDA product code for IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 is KOD.

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Official Source

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