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FDA 510(k)

CSTAT, MODELS 09-0014-01 AND 09-0014-02

K-Number: K032125 · 2004-02-09

ApplicantVascular Control Systems, Inc.
Decision Date2004-02-09
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSTAT, MODELS 09-0014-01 AND 09-0014-02 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 2004-02-09 under 510(k) number K032125. 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 CSTAT, MODELS 09-0014-01 AND 09-0014-02?

CSTAT, MODELS 09-0014-01 AND 09-0014-02 is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is Vascular Control Systems, Inc.. The 510(k) number is K032125.

When did CSTAT, MODELS 09-0014-01 AND 09-0014-02 receive FDA 510(k) clearance?

CSTAT, MODELS 09-0014-01 AND 09-0014-02 received FDA 510(k) clearance on 2004-02-09, under 510(k) number K032125.

Who is the listed applicant for CSTAT, MODELS 09-0014-01 AND 09-0014-02?

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 CSTAT, MODELS 09-0014-01 AND 09-0014-02?

The FDA product code for CSTAT, MODELS 09-0014-01 AND 09-0014-02 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 09-0023-01K031812TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03K031358TRANSVAGINAL 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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