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FDA 510(k)

ATLANTIS PV IMAGING CATHETER, MODEL 36456

K-Number: K022860 · 2002-11-21

ApplicantBoston Scientific, Target
Decision Date2002-11-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLANTIS PV IMAGING CATHETER, MODEL 36456 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific, Target. It received FDA 510(k) clearance on 2002-11-21 under 510(k) number K022860. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIS PV IMAGING CATHETER, MODEL 36456?

ATLANTIS PV IMAGING CATHETER, MODEL 36456 is a medical device that received FDA 510(k) clearance on 2002-11-21. The listed applicant is Boston Scientific, Target. The 510(k) number is K022860.

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

ATLANTIS PV IMAGING CATHETER, MODEL 36456 received FDA 510(k) clearance on 2002-11-21, under 510(k) number K022860.

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

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

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

The FDA product code for ATLANTIS PV IMAGING CATHETER, MODEL 36456 is ITX.

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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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