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FDA 510(k)

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

K-Number: K010128 · 2002-04-25

ApplicantCook Vascular, Inc.
Decision Date2002-04-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE 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 2002-04-25 under 510(k) number K010128. 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 PEEL-AWAY HEMOSTASIS VALVE?

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE is a medical device that received FDA 510(k) clearance on 2002-04-25. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K010128.

When did COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE receive FDA 510(k) clearance?

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE received FDA 510(k) clearance on 2002-04-25, under 510(k) number K010128.

Who is the listed applicant for COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE?

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 PEEL-AWAY HEMOSTASIS VALVE?

The FDA product code for COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE 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 SWITCHK023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

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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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