FDA 510(k)

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

K-Number: K041727 · 2004-07-23

Decision Date2004-07-23

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K041727. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456?

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K041727.

When did MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 receive FDA 510(k) clearance?

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041727.

Who is the listed applicant for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456?

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

What is the FDA product code for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456?

The FDA product code for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 is OBJ.

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Other records listing Boston Scientific Scimed, Inc. as applicant

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Related Devices (Code: OBJ)

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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.