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FDA 510(k)

TRANSVAGINAL DOPPLER PROBE

K-Number: K031358 · 2003-05-09

ApplicantVascular Control Systems, Inc.
Decision Date2003-05-09
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL DOPPLER PROBE 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 2003-05-09 under 510(k) number K031358. 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?

TRANSVAGINAL DOPPLER PROBE is a medical device that received FDA 510(k) clearance on 2003-05-09. The listed applicant is Vascular Control Systems, Inc.. The 510(k) number is K031358.

When did TRANSVAGINAL DOPPLER PROBE receive FDA 510(k) clearance?

TRANSVAGINAL DOPPLER PROBE received FDA 510(k) clearance on 2003-05-09, under 510(k) number K031358.

Who is the listed applicant for TRANSVAGINAL DOPPLER PROBE?

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?

The FDA product code for TRANSVAGINAL DOPPLER PROBE 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, 09-0016-03K030078BURBANK TENACULUM, MODEL 09-0011-01K023154VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02

View all 9 devices →

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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