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FDA 510(k)

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

K-Number: K023024 · 2002-09-26

ApplicantVascular Control Systems, Inc.
Decision Date2002-09-26
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Control Systems, Inc.. It received FDA 510(k) clearance on 2002-09-26 under 510(k) number K023024. 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 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02?

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 is a medical device that received FDA 510(k) clearance on 2002-09-26. The listed applicant is Vascular Control Systems, Inc.. The 510(k) number is K023024.

When did TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 receive FDA 510(k) clearance?

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 received FDA 510(k) clearance on 2002-09-26, under 510(k) number K023024.

Who is the listed applicant for TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02?

The FDA 510(k) record lists Vascular Control Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02?

The FDA product code for TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 is ITX.

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Other records listing Vascular Control Systems, Inc. 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.

K060573BURBANK TENACULUMK052209VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01K032125CSTAT, MODELS 09-0014-01 AND 09-0014-02K031812TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03K031358TRANSVAGINAL DOPPLER PROBEK030078BURBANK TENACULUM, MODEL 09-0011-01

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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