Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023154 ↗

FDA Product Code

DXC

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vcs-A Series Clamp

  Class II

  FDA 510(k) K011863 Active Cleared 15 Feb 2002

• Transvaginal Doppler Probe

  Class II

  FDA 510(k) K031358 Active Cleared 9 May 2003

• Transvaginal Doppler Probe, Model 09-0006-02

  Class II

  FDA 510(k) K023024 Active Cleared 26 Sep 2002

• Burbank Tenaculum

  Class II

  FDA 510(k) K060573 Active Cleared 21 Apr 2006

• Vcs Doppler Transceiver, Model 09-0023-01

  Class II

  FDA 510(k) K052209 Active Cleared 6 Sep 2005

• Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03

  Class II

  FDA 510(k) K031812 Active Cleared 12 Dec 2003

See all devices from Vascular Control Systems, Inc. →

• What is the primary purpose of the VCS-A Series Clamp with Doppler Ultrasound?

  The VCS-A Series Clamp with Doppler Ultrasound is designed to temporarily occlude blood vessels during surgical procedures, particularly in cardiovascular applications. The integrated 8 MHz pulsed-wave Doppler ultrasound sensor provides real-time audible feedback to confirm whether blood flow is present or absent, ensuring accurate vessel control during surgery.

• How is the VCS-A Series Clamp with Doppler Ultrasound supplied and prepared for use?

  This device is supplied as a reusable surgical instrument. Before each use, it must undergo proper sterilization to maintain sterile conditions in the operating room. The stainless steel construction and ring-handled design are engineered for durability and ease of manipulation during surgical procedures.

• Are the models 09-0007-01 and 09-0007-02 intended for single-use or reusable?

  The models 09-0007-01 and 09-0007-02 are reusable instruments. However, they are intended for single-patient use per sterilization cycle, adhering to standard surgical instrument protocols to ensure patient safety and prevent cross-contamination.

• What materials is the VCS-A Series Clamp with Doppler Ultrasound made from?

  The clamp is constructed from stainless steel, which provides strength, durability, and resistance to corrosion. This material is ideal for surgical instruments, ensuring they remain reliable and maintain their integrity through repeated sterilization cycles.

• Is there any specific guidance regarding MRI safety for this device?

  The available data does not provide explicit MRI safety information for the VCS-A Series Clamp with Doppler Ultrasound. Clinicians should consult additional resources or manufacturer guidelines if MRI compatibility is a concern for their specific use case.