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FDA 510(k)

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

K-Number: K023937 · 2003-05-27

ApplicantCook Vascular, Inc.
Decision Date2003-05-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM 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 2003-05-27 under 510(k) number K023937. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM?

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-27. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K023937.

When did COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM receive FDA 510(k) clearance?

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM received FDA 510(k) clearance on 2003-05-27, under 510(k) number K023937.

Who is the listed applicant for COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM?

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 VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM?

The FDA product code for COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM is DYB.

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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 SWITCHK022649COOK-SWARTZ DOPPLER FLOW PROBE

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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