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FDA 510(k)

TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03

K-Number: K031812 · 2003-12-12

ApplicantVascular Control Systems, Inc.
Decision Date2003-12-12
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 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 2003-12-12 under 510(k) number K031812. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03?

TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Vascular Control Systems, Inc.. The 510(k) number is K031812.

When did TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 receive FDA 510(k) clearance?

TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 received FDA 510(k) clearance on 2003-12-12, under 510(k) number K031812.

Who is the listed applicant for TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03?

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 CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03?

The FDA product code for TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 is DXC.

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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 09-0014-02K031358TRANSVAGINAL DOPPLER PROBEK030078BURBANK TENACULUM, MODEL 09-0011-01K023154VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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