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FDA 510(k)

DOPPLER MONITOR

K-Number: K110347 · 2011-03-16

ApplicantCook Vascular, Inc.
Decision Date2011-03-16
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPPLER MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cook Vascular, Inc.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K110347. 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 DOPPLER MONITOR?

DOPPLER MONITOR is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K110347.

When did DOPPLER MONITOR receive FDA 510(k) clearance?

DOPPLER MONITOR received FDA 510(k) clearance on 2011-03-16, under 510(k) number K110347.

Who is the listed applicant for DOPPLER MONITOR?

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

What is the FDA product code for DOPPLER MONITOR?

The FDA product code for DOPPLER MONITOR is DPW.

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Other records listing Cook Vascular, 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.

K083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SETK081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORTK061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0K032223COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCHK023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEMK022649COOK-SWARTZ DOPPLER FLOW PROBE

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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