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FDA 510(k)

VASCULAR ASSIST

K-Number: K002186 · 2001-05-02

ApplicantHuntleigh Healthcare, Inc.
Decision Date2001-05-02
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K002186. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR ASSIST?

VASCULAR ASSIST is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K002186.

When did VASCULAR ASSIST receive FDA 510(k) clearance?

VASCULAR ASSIST received FDA 510(k) clearance on 2001-05-02, under 510(k) number K002186.

Who is the listed applicant for VASCULAR ASSIST?

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

What is the FDA product code for VASCULAR ASSIST?

The FDA product code for VASCULAR ASSIST is DPW.

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Other records listing Huntleigh Healthcare, Inc. as applicant

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Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington 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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