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FDA 510(k)

ULTRAGUIDE CTG 2000SA

K-Number: K022354 · 2002-08-13

ApplicantUltraguide , Ltd.
Decision Date2002-08-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAGUIDE CTG 2000SA is the device name listed in this FDA 510(k) record. The listed applicant is Ultraguide , Ltd.. It received FDA 510(k) clearance on 2002-08-13 under 510(k) number K022354. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAGUIDE CTG 2000SA?

ULTRAGUIDE CTG 2000SA is a medical device that received FDA 510(k) clearance on 2002-08-13. The listed applicant is Ultraguide , Ltd.. The 510(k) number is K022354.

When did ULTRAGUIDE CTG 2000SA receive FDA 510(k) clearance?

ULTRAGUIDE CTG 2000SA received FDA 510(k) clearance on 2002-08-13, under 510(k) number K022354.

Who is the listed applicant for ULTRAGUIDE CTG 2000SA?

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

What is the FDA product code for ULTRAGUIDE CTG 2000SA?

The FDA product code for ULTRAGUIDE CTG 2000SA is JAK.

Related Clinical Trials

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Other records listing Ultraguide , Ltd. 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.

K023227USG 2000SAK013150MR-GUIDE 2000K011418ULTRAGUIDE MR-GUIDE 3000K002258ULTRAGUIDE CT-GUIDE 1010K974432ULTRAGUIDE 1000

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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