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FDA 510(k)

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET

K-Number: K083482 · 2009-04-02

ApplicantCook Vascular, Inc.
Decision Date2009-04-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET 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 2009-04-02 under 510(k) number K083482. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET?

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K083482.

When did COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET receive FDA 510(k) clearance?

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET received FDA 510(k) clearance on 2009-04-02, under 510(k) number K083482.

Who is the listed applicant for COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET?

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 VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET?

The FDA product code for COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET is FPA.

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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 MONITORK081425COOK 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: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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