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FDA 510(k)

SHAPEABLE DOPPLER FLOW PROBE

K-Number: K002958 · 2001-12-18

ApplicantCook Vascular, Inc.
Decision Date2001-12-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHAPEABLE DOPPLER FLOW PROBE 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 2001-12-18 under 510(k) number K002958. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAPEABLE DOPPLER FLOW PROBE?

SHAPEABLE DOPPLER FLOW PROBE is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K002958.

When did SHAPEABLE DOPPLER FLOW PROBE receive FDA 510(k) clearance?

SHAPEABLE DOPPLER FLOW PROBE received FDA 510(k) clearance on 2001-12-18, under 510(k) number K002958.

Who is the listed applicant for SHAPEABLE DOPPLER FLOW PROBE?

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 SHAPEABLE DOPPLER FLOW PROBE?

The FDA product code for SHAPEABLE DOPPLER FLOW PROBE is ITX.

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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.

K110347DOPPLER MONITORK083482COOK 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 SYSTEM

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna 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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