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FDA 510(k)

CVD BULLETT PERIPHERAL INFUSION CATHETER

K-Number: K943023 · 1994-09-30

ApplicantCardiovascular Dynamics, Inc.
Decision Date1994-09-30
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CVD BULLETT PERIPHERAL INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Dynamics, Inc.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K943023. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVD BULLETT PERIPHERAL INFUSION CATHETER?

CVD BULLETT PERIPHERAL INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Cardiovascular Dynamics, Inc.. The 510(k) number is K943023.

When did CVD BULLETT PERIPHERAL INFUSION CATHETER receive FDA 510(k) clearance?

CVD BULLETT PERIPHERAL INFUSION CATHETER received FDA 510(k) clearance on 1994-09-30, under 510(k) number K943023.

Who is the listed applicant for CVD BULLETT PERIPHERAL INFUSION CATHETER?

The FDA 510(k) record lists Cardiovascular Dynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CVD BULLETT PERIPHERAL INFUSION CATHETER?

The FDA product code for CVD BULLETT PERIPHERAL INFUSION CATHETER is FOZ.

Related Clinical Trials

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.

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Other records listing Cardiovascular Dynamics, 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.

K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CARK971577FOCUS-PV BALLOON DILATATION CATHETERK963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICEK963688FOCUS PV BALLOON DILATATION CATHETERK945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETERK952064FOCUS BALLOON DILATATION CATHETER

View all 11 devices →

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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