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FDA 510(k)

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE

K-Number: K034059 · 2004-03-09

ApplicantSectra AB
Decision Date2004-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K034059. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE?

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Sectra AB. The 510(k) number is K034059.

When did SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE receive FDA 510(k) clearance?

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE received FDA 510(k) clearance on 2004-03-09, under 510(k) number K034059.

Who is the listed applicant for SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE?

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

What is the FDA product code for SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE?

The FDA product code for SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE is LLZ.

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Other records listing Sectra AB as applicant

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.

K232208Sectra Digital Pathology Module (Version 3.3)K193054Sectra Digital Pathology ModuleK033088SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1K001140IDS5 IMAGE DISPLAY SYSTEM

Related Devices (Code: LLZ)

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.

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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.

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