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FDA 510(k)

COOK-SWARTZ DOPPLER FLOW PROBE

K-Number: K022649 · 2002-09-06

ApplicantCook Vascular, Inc.
Decision Date2002-09-06
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COOK-SWARTZ 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 2002-09-06 under 510(k) number K022649. 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 COOK-SWARTZ DOPPLER FLOW PROBE?

COOK-SWARTZ DOPPLER FLOW PROBE is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K022649.

When did COOK-SWARTZ DOPPLER FLOW PROBE receive FDA 510(k) clearance?

COOK-SWARTZ DOPPLER FLOW PROBE received FDA 510(k) clearance on 2002-09-06, under 510(k) number K022649.

Who is the listed applicant for COOK-SWARTZ 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 COOK-SWARTZ DOPPLER FLOW PROBE?

The FDA product code for COOK-SWARTZ 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)

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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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