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FDA 510(k)

ATLANTIS 018 PERIPHERAL IMAGING CATHETER

K-Number: K073623 · 2008-03-13

ApplicantBoston Scientific Corp
Decision Date2008-03-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLANTIS 018 PERIPHERAL IMAGING CATHETER 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 2008-03-13 under 510(k) number K073623. 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 018 PERIPHERAL IMAGING CATHETER?

ATLANTIS 018 PERIPHERAL IMAGING CATHETER is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K073623.

When did ATLANTIS 018 PERIPHERAL IMAGING CATHETER receive FDA 510(k) clearance?

ATLANTIS 018 PERIPHERAL IMAGING CATHETER received FDA 510(k) clearance on 2008-03-13, under 510(k) number K073623.

Who is the listed applicant for ATLANTIS 018 PERIPHERAL IMAGING CATHETER?

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 ATLANTIS 018 PERIPHERAL IMAGING CATHETER?

The FDA product code for ATLANTIS 018 PERIPHERAL IMAGING CATHETER is ITX.

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Related Devices (Code: 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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